Girish Munavalli - Academia.edu (original) (raw)
Papers by Girish Munavalli
Journal of the American Academy of Dermatology
Archives of Dermatological Research
We present the first reported cases of delayed inflammatory reactions (DIR) to hyaluronic acid (H... more We present the first reported cases of delayed inflammatory reactions (DIR) to hyaluronic acid (HA) dermal fillers after exposure to the COVID-19 spike protein. DIR to HA is reported to occur in the different scenarios including: secondary to poor injection technique, following dental cleaning procedures, following bacterial/viral illness, and after vaccination. In this report of 4 cases with distinct clinical histories and presentations: one case occured following a community acquired COVID-19 infection, one case occured in a study subject in the mRNA-1273 clinical phase III trial, one case occurred following the first dose of publically available mRNA-1273 vaccine (Moderna, Cambridge MA), and the last case occurred after the second dose of BNT162b2 vaccine (Pfizer, New York, NY). Injectable HA dermal fillers are prevalent in aesthetic medicine for facial rejuvenation. Structural modifications in the crosslinking of HA fillers have enhanced the products' resistance to enzymatic breakdown and thus increased injected product longevity, however, have also led to a rise in DIR. Previous, DIR to HA dermal fillers can present clinically as edema with symptomatic and inflammatory erythematous papules and nodules. The mechanism of action for the delayed reaction to HA fillers is unknown and is likely to be multifactorial in nature. A potential mechanism of DIR to HA fillers in COVID-19 related cases is binding and blockade of angiotensin 2 converting enzyme receptors (ACE2), which are targeted by the SARS-CoV-2 virus spike protein to gain entry into the cell. Spike protein interaction with dermal ACE2 receptors favors a pro-inflammatory, loco-regional TH1 cascade, promoting a CD8+T cell mediated reaction to incipient granulomas, which previously formed around residual HA particles. Management to suppress the inflammatory response in the native COVID-19 case required high-dose corticosteroids (CS) to suppress inflammatory pathways, with concurrent ACE2 upregulation, along with high-dose intralesional hyaluronidase to dissolve the inciting HA filler. With regards to the two vaccine related cases; in the mRNA-1273 case, a low dose angiotensin converting enzyme inhibitor (ACE-I) was utilized for treatment, to reduce pro-inflammatory Angiotensin II. Whereas, in the BNT162b2 case the filler reaction was suppressed with oral corticosteroids. Regarding final disposition of the cases; the vaccine-related cases returned to baseline appearance within 3 days, whereas the native COVID-19 case continued to have migratory, evanescent, periorbital edema for weeks which ultimately subsided.
Lasers in Surgery and Medicine
Dermatologic Surgery
BACKGROUND Submental fat (SMF) can negatively affect perceptions of health and attractiveness. Th... more BACKGROUND Submental fat (SMF) can negatively affect perceptions of health and attractiveness. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to understand SMF treatment in clinical practice. OBJECTIVE To report efficacy, treatment characteristics, and safety associated with real-world use of ATX-101 (deoxycholic acid injection). METHODS CONTOUR enrolled adults considering treatment for SMF reduction. ATX-101-treated patients who completed the end-of-treatment questionnaire were divided into those who ended treatment because they met their treatment goals (n = 197) and those who did not (n = 196). RESULTS Patients who met their goals (a more defined jawline, looking younger, and looking thinner) were more likely to have less SMF at baseline and to receive ≥2 ATX-101 treatments. More patients who met their goals achieved clinically meaningful reduction in SMF and reported increased satisfaction with their appearance (90% vs 57%). Moderate and severe patients' ATX-101 volume was similar for both those who met goals and those who did not, but extreme patients who met their goals required 10 mL more than those patients who did not. CONCLUSION Careful patient selection, adequate volume administration, and an appropriate number of treatments (dependent on baseline SMF severity) contribute to successful outcomes with ATX-101.
Journal of drugs in dermatology : JDD, 2016
Recent appreciation of the multifactorial pathophysiology of skin aging has led to increased use ... more Recent appreciation of the multifactorial pathophysiology of skin aging has led to increased use of parallel treatment regimens. This prospective, split-face, randomized study assessed the safety and efficacy of same-day sequential Q-switched Nd:YAG laser and 1565 nm non-ablative fractional laser (SST) facial rejuvenation treatment in comparison to fractional non-ablative laser (NAFL) treatment only. Seventeen patients underwent three treatment sessions, conducted at 4-6-week intervals, in which SST treatment was delivered on a randomly selected side of the face followed by NAFL treatment on the contralateral side immediately thereafter. Immediate skin responses were assessed within 30 minutes of treatment, while wrinkle/elastosis scores, and skin tone and texture were evaluated 1, 3, and 6 months following the final treatment session. While SST and NAFL proved equally safe, SST was associated with signi cantly lower pain scores in all three treatment sessions. Both treatment regime...
JAMA dermatology, Jan 28, 2017
The notion that systemic isotretinoin taken within 6 to 12 months of cutaneous surgery contribute... more The notion that systemic isotretinoin taken within 6 to 12 months of cutaneous surgery contributes to abnormal scarring or delayed wound healing is widely taught and practiced; however, it is based on 3 small case series from the mid-1980s. To evaluate the body of literature to provide evidence-based recommendations regarding the safety of procedural interventions performed either concurrently with, or immediately following the cessation of systemic isotretinoin therapy. A panel of national experts in pediatric dermatology, procedural/cosmetic dermatology, plastic surgery, scars, wound healing, acne, and isotretinoin was convened. A systematic PubMed review of English-language articles published from 1982 to 2017 was performed using the following search terms: isotretinoin, 13-cis-retinoic acid, Accutane, retinoids, acitretin, surgery, surgical, laser, ablative laser, nonablative laser, laser hair removal, chemical peel, dermabrasion, wound healing, safety, scarring, hypertrophic sc...
Dermatologic Surgery, 2016
Schick and colleagues have performed a thorough well-designed study on the use of radiofrequency ... more Schick and colleagues have performed a thorough well-designed study on the use of radiofrequency (RF) for the treatment of axillary hyperhidrosis, a debilitating medical disorder with a marked effect on the quality of life. In this case, RF energy is delivered in an array of 5 · 5 noninsulated (unsheathed) needle electrodes with a diameter of 0.3 mm at varying depths of 3 and 2 mm in a 2-pass technique. Multiple treatments were necessary. At 6 months after the last treatment, subjective end points of Hyperhidrosis Disease Severity Scale and Dermatology Quality of Life Index were measured and objective gravimetric measurements (baseline vs postprovocation) were performed. Results showed that safety was well maintained with minimal downtime, and impressively an approximate 10-fold reduction in gravimetric readings and 90% subject survey satisfaction in this small sample size of patients, who had previously failed other medical therapies to control their excessive sweating.
Lasers in Surgery and Medicine, 2016
The aging process is commonly associated with skin laxity in the lower face and neck. Conventiona... more The aging process is commonly associated with skin laxity in the lower face and neck. Conventional surgery can correct this at least to some extent, but is invasive. Fractional high-intensity focused radiofrequency delivered to the dermis with insulated microneedles has recently attracted attention in facial rejuvenation. The present pilot study was designed to assess the efficacy of HiFR for skin laxity of the lower face and neck. Thirty-three patients (7 males, 26 females, age range 37-74 years) with mild to moderate skin laxity of the lower face/neck participated in the study. Three treatments were given at monthly intervals with protocols developed by the authors, three passes per session, at decreasing dermal depths for each pass. Histologic assessment of skin immediately after treatment was performed to identify the site and area of damage in the dermis. Clinical digital photography was taken at baseline and at 6 months after the final treatment session, based on which standardized computer measurement of improvement in the gnathion and cervicomental angles was the primary objective evaluation. A global assessment of improvement was graded by blinded assessors based on the photography. A telephone survey of patient satisfaction was performed at 12 months post-treatment. A significant post-treatment decrease in the cervicomental and gnathion angles was seen of 28.5° and 16.6°, respectively (P < 0.0001 for both). Histology immediately post-treatment showed a clear demarcated and roughly oval area of coagulation associated with the tip of the needle, confined to the dermis and not involving the epidermis. In the global assessment 81.8% of the patients achieved moderate or higher results, and 87% of patients were very satisfied or better. Downtime was minimal, lasting 3-4 days, and no persistent adverse events were recorded. Fractional HiFR proved safe and effective in the treatment of neck laxity in a large age range of patients, including the elderly. Lasers Surg. Med. 48:461-470, 2016. © 2016 Wiley Periodicals, Inc.
Journal of Drugs in Dermatology Jdd, Sep 1, 2006
Background and Objectives: Monopolar radiofrequency skin heating coupled with cryogen cooling of ... more Background and Objectives: Monopolar radiofrequency skin heating coupled with cryogen cooling of facial skin for skin tightening has been utilized on over 10,000 patients since 2002. In order to establish the actual rate and degree of side effects in our clinical experience, a retrospective chart review was performed. Study Design: Charts and clinical images of over 600 consecutive patient treatments between May 2002 and June 2006 using a monopolar radiofrequency device (Thermacool ® , Thermage, Haywood, CA) for skin tightening at the Maryland Laser, Skin and Vein Institute were retrospectively reviewed. The primary presentation for treatment was skin laxity of the lower face. Treatment was delivered with a 1-cm 2 standard tip at fluences of 81 to 124 J/cm 2 (level of 12.5 to 15), a 1-cm 2 "fast" tip at fluences of 62 to 109 J/cm 2 (level of 72.0 to 76.0), a 1.5-cm 2 "big fast" tip at fluences of 75 to 130 J/cm 2 (level of 61.5 to 65), and a 3-cm 2 "bigger" tip at equivalent fluences as each became available. As treatment algorithms evolved over 4 years, the algorithm of multiple passes at lower fluence associated with better clinical outcomes and greater patient acceptance has been adopted. Results: The most common immediate and expected clinical effects were erythema and edema lasting less than 24 hours, although 6 patients reported edema lasting for up to 1 week. There were no permanent side effects. In total, 2.7% of treatments resulted in temporary side effects, the most significant of which was a slight depression on the cheek (n = 1), which completely resolved within 3.5 months. Other side effects included localized areas of acneiform subcutaneous erythematous papules (n = 4) and a linear superficial crust (n = 1) with the original tip, all of which resolved within 1 week. One patient reported small erythematous subcutaneous nodules resolving in 17 days. Tenderness of the neck lasting from 2 weeks (n = 2) to 3 weeks (n = 1) was also reported. Conclusions: Our data, obtained in an office setting without injectable anesthetic or IV sedation, indicate that monopolar RF for skin tightening is a very safe procedure. The treatment algorithm and tips have evolved over several years leading to increased safety and efficacy. Side effects are infrequent, self-limited, and minor, comparing favorably to other nonablative devices utilized for facial rejuvenation.
Dermatologic Surgery, 2015
Pseudogynecomastia refers to benign male breast enlargement due to excess subareolar fat. Standar... more Pseudogynecomastia refers to benign male breast enlargement due to excess subareolar fat. Standard treatment is surgical excision under general anesthesia, liposuction, or a combination of both. The safety and efficacy of cryolipolysis was investigated for nonsurgical treatment of pseudogynecomastia. Enrollment consisted of 21 males with pseudogynecomastia. Subjects received a first treatment consisting of a 60-minute cryolipolysis cycle, followed by a two-minute massage, and a second 60-minute cycle with 50% treatment area overlap. At 60 days of follow-up, subjects received a second 60-minute treatment. Safety was evaluated by monitoring side effects and adverse events. Efficacy was assessed by ultrasound, clinical photographs, and subject surveys. Surveys revealed that 95% of subjects reported improved visual appearance and 89% reported reduced embarrassment associated with pseudogynecomastia. Ultrasound showed mean fat layer reduction of 1.6 ± 1.2 mm. Blinded reviewers correctly identified 82% of baseline photographs. Side effects included mild discomfort during treatment and transient paresthesia and tenderness. One case of paradoxical hyperplasia (PH) occurred but likelihood of PH in the male breast is not believed to be greater than in any other treatment area. This study demonstrated feasibility of cryolipolysis for safe, effective, and well-tolerated nonsurgical treatment of pseudogynecomastia.
Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology, 2008
Acne is a very prevalent skin disorder, and several devices, such as blue light, pulsed dye laser... more Acne is a very prevalent skin disorder, and several devices, such as blue light, pulsed dye laser, diode laser, LED, RF and pulsed light systems, have been reported to have varying degrees of efficacy for treatment. Photopneumatic therapy (PPX) is a novel technology that combines pneumatic energy with a broadband light source to manipulate the optical characteristics of the skin. A vacuum suction raises target structures in the dermis closer to the surface of the skin prior to exposure, allowing for more efficient energy transmission. This study tested the hypothesis that a combination of pulsed light and suction would affect sebaceous plugging within diseased pilosebaceous apparati at a histological level, resulting in the rapid clearance of acne lesions. Eight individuals were treated with PPX once per week for a total of five treatments. Punch biopsies of the treated areas were obtained just after the first exposure, just before the third exposure and immediately after the fifth ...
Journal of drugs in dermatology : JDD, 2006
The use of thermal heating in microscopic zones is generically termed "microrejuvenation.&qu... more The use of thermal heating in microscopic zones is generically termed "microrejuvenation." The objective of this study was to evaluate the benefits of using a novel 1440-nm Nd:YAG laser (Affirm, Cynosure, Westford, MA) with a novel approach for microscopic heating. This device utilizes a microarray of lenses delivering a 10-mm beam as hundreds of high-fluence beamlets interspersed with a relatively uniform low-fluence background irradiation. Forty subjects (N = 40) at 2 study sites presenting with superficial rhytides and other symptoms of photoaging or scars received 3 treatments at 4-week intervals using a T-250 lens array. Total fluence ranged from 3.0 to 7.0 J/cm2. Zimmer air cooling was used for all treatments. No topical anesthetic was required. The most common immediate and expected clinical effects were erythema and edema lasting less than 24 hours, although 6 patients reported edema lasting for up to 1 week. There were no permanent side effects. In total, 2.7% of ...
Lasers in Surgery and Medicine, 2015
Lichen amyloidosis is characterized by amyloid deposition in the papillary dermis, presenting cli... more Lichen amyloidosis is characterized by amyloid deposition in the papillary dermis, presenting clinically with intensely pruritic hyperkeratotic papules. Various treatment modalities have been used but the results are generally unsatisfactory. Several studies show that non-ablative fractional lasers can be used to treat depositional diseases due to their capability of inducing transepidermal elimination of the dermal content. To investigate the efficacy and safety of a non-ablative fractional 1,550 nm Yttrium/Erbium fiber laser for the treatment of lichen amyloidosis. Ten subjects with a clinical and histological diagnosis of lichen amyloidosis were treated with fractional non-ablative laser using a 7-cm tip, with the parameter of 30 mJ/cm(2) and 1,000 microscopic treatment zones (MTZ)/cm(2) for three sessions at 4-week intervals. Clinical improvement (in terms of global improvement score, brownish/hyperpigmentation, thickness, and number of papules) was evaluated using a quartile grading scale at baseline, and 4, 12, and 24 weeks after the last treatment. Itch score and subjective satisfaction rates were also assessed. Adverse events were recorded, and pain was scored using a visual analog scale (VAS). Histologic changes were observed using standard staining with hematoxylin and eosin, as well as special stains of alkaline congo red and crystal violet at baseline and 4 weeks after treatment. At 4 and 24 weeks after treatment, the lichen amyloid lesions had statistically significantly improved in all aspects compared to baseline (P = 0.01 and P = 0.016, respectively; Wilcoxon signed-rank test). However, partial recurrence was reported in 2 out of 10 subjects. All subjects rated itching symptom significantly improved after only the first treatment (P < 0.05). Minimal side effects were recorded, including a burning sensation, transient erythema, and edema. Histological evaluation demonstrated decreased epidermal thickness, and degeneration and shrinkage of amyloid material deposition in the papillary dermis. There was no amyloid material deposition noted in two out of eight histopathology studies. The non-ablative fractional 1,550 nm Ytterbium/Erbium fiber laser is safe and effective for the treatment of lichen amyloidosis. However, larger controlled studies are required to further establish the efficacy of this treatment. Lasers Surg. Med. 47:222-230, 2015. © 2015 Wiley Periodicals, Inc.
The effect of sulfur mustard (SM, bis-(2-chloroethyl) sulfide) on intracellular free Ca-÷ concent... more The effect of sulfur mustard (SM, bis-(2-chloroethyl) sulfide) on intracellular free Ca-÷ concentration ((Ca2]i) was studied in vitro using the clonal mouse neuroblastoma-rat glioma hybrid NG108-15 and primary normal human epidermal keratinocyte (NHEK) cell culture models. SM depletes cellular glutathione (GSH) and thus may inhibit GSH-dependent Ca 2 ÷-ATPase (Ca2* pump), leading to a high (Ca 2-]i and consequent cellular toxicity. Following 0.3 mM SM exposure, GSH levels decreased 20-34% between 1-6 hr in NG108-15 cells. SM increased [Ca 2 +]I, measured using the Ca 2 ÷-specific fluorescent probe Fluo-3 AM, in both NG108-15 cells (10-30% between 2-6 hr) and NHEK (23-30% between 0.5-3 hr). Depletion of cellular GSH by buthionine sulfoximine (I mM), a specific GSH biosynthesis inhibitor, also increased (Ca2*, (88% at 1 hr) in NHEK, suggesting that GSH depletion may lead to increased (Ca2*] 1. Calcium, localized cytochemically with antimony, accumulated in increased amounts around mitochondria and endoplasmic reticula, in the cytosol, and in particular in the euchromatin regions of the nucleus beginning at 6 hr after 0.3 mM SM exposure of NG108-15 cells.
Medical Laser Application, 2008
Acne is a very prevalent skin disorder and several devices (such as blue light, pulsed dye laser,... more Acne is a very prevalent skin disorder and several devices (such as blue light, pulsed dye laser, diode laser, LEDs, RF, and pulsed light) have been reported to have varying degrees of efficacy for treatment. Pulsed light treatments have been used both alone and in combination with other modalities to rapidly reduce active acne. Photopneumatic therapy is a novel technology
Seminars in Cutaneous Medicine and Surgery, 2008
Acne is a very prevalent skin disorder, affecting more than 85% of adolescents and often continui... more Acne is a very prevalent skin disorder, affecting more than 85% of adolescents and often continuing into adulthood. Active acne and its sequelae, especially permanent scarring, may cause longstanding psychological or emotional harm in patients. Novel and promising treatments with laser/light devices (such as blue light, red light, pulsed dye laser, infrared lasers, light-emitting diodes, and pulsed light) have been reported to have varying degrees of efficacy for treatment. The authors compiled a summary of evidence-based literature on laser/light treatment for acne to assist clinicians to more appropriately identify treatment options, should they choose to supplement current medical antiacne therapies.
Seminars in Cutaneous Medicine and Surgery, 2007
Sclerotherapy is the systematic, targeted elimination of intracutaneous and subcutaneous varicose... more Sclerotherapy is the systematic, targeted elimination of intracutaneous and subcutaneous varicose, reticular, telangiectasias by the injection of a locally irritating chemical substance, called a sclerosant. The endpoint of this process is functionally analogous to surgical removal of a vein. However, regardless of the best of intentions, complications can and will occur with enough sclerotherapy treatments. Complications resulting from sclerotherapy can be divided into the following categories for ease of explanation: (1) frequent but transient, (2) rare but self-limited, and (3) rare but major. This article will focus on select complications in sclerotherapy, review the most common complications observed, and discuss how to minimize these in daily practice.
Lasers in surgery and medicine, 2015
Persistent post-acne erythema is one of the most common aesthetic sequelae to arise after active ... more Persistent post-acne erythema is one of the most common aesthetic sequelae to arise after active acne resolves. The treatment remains challenging due to lack of effective laser modalities. To evaluate the safety and efficacy of a low-fluence 585 nm Q-switched Nd:YAG laser for the treatment of post-acne erythema. Twenty-five patients with post-acne erythema were treated with a low-fluence Q-switched Nd:YAG laser using the 585 nm Gold Toning™ handpiece (5 mm spot size, 5-10 ns, 0.30-0.55 J/cm(2) , 2-4 passes) for three sessions at 2-week intervals. Erythema lesion (macules) count, inflammatory acne (papules, pustules) count, erythema index, degree of post-acne erythema and overall improvement in post-acne erythema and acne scar were assessed at baseline, every 2 weeks and 6 weeks after the last treatment. Subjective degrees of satisfaction were also evaluated. Adverse events were recorded and pain was scored using a visual analog scale (VAS). At 6 weeks after 3 sessions of laser treat...
Seminars in cutaneous medicine and surgery, 2005
The use of endovenous procedures to eliminate saphenous and primary branch reflux has been growin... more The use of endovenous procedures to eliminate saphenous and primary branch reflux has been growing exponentially over the last few years. Although initially developed by dermatologic surgeons, the technique has been embraced by many other specialties including radiology, vascular surgery and anesthesiology. Radiofrequency energy was the first used in 1999 for endovenous ablation. More recently, laser technology targeting hemoglobin (810 nm, 940 nm & 980 nm) and water (1320 nm) have been developed to quickly and effectively treat saphenous reflux, with minimal side effects. The placement of peri-vascular anesthesia, using the tumescent technique, has further streamlined these procedures. The purpose of this article is to review our experience and outline advantages and disadvantages of the various techniques available.
Journal of the American Academy of Dermatology
Archives of Dermatological Research
We present the first reported cases of delayed inflammatory reactions (DIR) to hyaluronic acid (H... more We present the first reported cases of delayed inflammatory reactions (DIR) to hyaluronic acid (HA) dermal fillers after exposure to the COVID-19 spike protein. DIR to HA is reported to occur in the different scenarios including: secondary to poor injection technique, following dental cleaning procedures, following bacterial/viral illness, and after vaccination. In this report of 4 cases with distinct clinical histories and presentations: one case occured following a community acquired COVID-19 infection, one case occured in a study subject in the mRNA-1273 clinical phase III trial, one case occurred following the first dose of publically available mRNA-1273 vaccine (Moderna, Cambridge MA), and the last case occurred after the second dose of BNT162b2 vaccine (Pfizer, New York, NY). Injectable HA dermal fillers are prevalent in aesthetic medicine for facial rejuvenation. Structural modifications in the crosslinking of HA fillers have enhanced the products' resistance to enzymatic breakdown and thus increased injected product longevity, however, have also led to a rise in DIR. Previous, DIR to HA dermal fillers can present clinically as edema with symptomatic and inflammatory erythematous papules and nodules. The mechanism of action for the delayed reaction to HA fillers is unknown and is likely to be multifactorial in nature. A potential mechanism of DIR to HA fillers in COVID-19 related cases is binding and blockade of angiotensin 2 converting enzyme receptors (ACE2), which are targeted by the SARS-CoV-2 virus spike protein to gain entry into the cell. Spike protein interaction with dermal ACE2 receptors favors a pro-inflammatory, loco-regional TH1 cascade, promoting a CD8+T cell mediated reaction to incipient granulomas, which previously formed around residual HA particles. Management to suppress the inflammatory response in the native COVID-19 case required high-dose corticosteroids (CS) to suppress inflammatory pathways, with concurrent ACE2 upregulation, along with high-dose intralesional hyaluronidase to dissolve the inciting HA filler. With regards to the two vaccine related cases; in the mRNA-1273 case, a low dose angiotensin converting enzyme inhibitor (ACE-I) was utilized for treatment, to reduce pro-inflammatory Angiotensin II. Whereas, in the BNT162b2 case the filler reaction was suppressed with oral corticosteroids. Regarding final disposition of the cases; the vaccine-related cases returned to baseline appearance within 3 days, whereas the native COVID-19 case continued to have migratory, evanescent, periorbital edema for weeks which ultimately subsided.
Lasers in Surgery and Medicine
Dermatologic Surgery
BACKGROUND Submental fat (SMF) can negatively affect perceptions of health and attractiveness. Th... more BACKGROUND Submental fat (SMF) can negatively affect perceptions of health and attractiveness. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to understand SMF treatment in clinical practice. OBJECTIVE To report efficacy, treatment characteristics, and safety associated with real-world use of ATX-101 (deoxycholic acid injection). METHODS CONTOUR enrolled adults considering treatment for SMF reduction. ATX-101-treated patients who completed the end-of-treatment questionnaire were divided into those who ended treatment because they met their treatment goals (n = 197) and those who did not (n = 196). RESULTS Patients who met their goals (a more defined jawline, looking younger, and looking thinner) were more likely to have less SMF at baseline and to receive ≥2 ATX-101 treatments. More patients who met their goals achieved clinically meaningful reduction in SMF and reported increased satisfaction with their appearance (90% vs 57%). Moderate and severe patients' ATX-101 volume was similar for both those who met goals and those who did not, but extreme patients who met their goals required 10 mL more than those patients who did not. CONCLUSION Careful patient selection, adequate volume administration, and an appropriate number of treatments (dependent on baseline SMF severity) contribute to successful outcomes with ATX-101.
Journal of drugs in dermatology : JDD, 2016
Recent appreciation of the multifactorial pathophysiology of skin aging has led to increased use ... more Recent appreciation of the multifactorial pathophysiology of skin aging has led to increased use of parallel treatment regimens. This prospective, split-face, randomized study assessed the safety and efficacy of same-day sequential Q-switched Nd:YAG laser and 1565 nm non-ablative fractional laser (SST) facial rejuvenation treatment in comparison to fractional non-ablative laser (NAFL) treatment only. Seventeen patients underwent three treatment sessions, conducted at 4-6-week intervals, in which SST treatment was delivered on a randomly selected side of the face followed by NAFL treatment on the contralateral side immediately thereafter. Immediate skin responses were assessed within 30 minutes of treatment, while wrinkle/elastosis scores, and skin tone and texture were evaluated 1, 3, and 6 months following the final treatment session. While SST and NAFL proved equally safe, SST was associated with signi cantly lower pain scores in all three treatment sessions. Both treatment regime...
JAMA dermatology, Jan 28, 2017
The notion that systemic isotretinoin taken within 6 to 12 months of cutaneous surgery contribute... more The notion that systemic isotretinoin taken within 6 to 12 months of cutaneous surgery contributes to abnormal scarring or delayed wound healing is widely taught and practiced; however, it is based on 3 small case series from the mid-1980s. To evaluate the body of literature to provide evidence-based recommendations regarding the safety of procedural interventions performed either concurrently with, or immediately following the cessation of systemic isotretinoin therapy. A panel of national experts in pediatric dermatology, procedural/cosmetic dermatology, plastic surgery, scars, wound healing, acne, and isotretinoin was convened. A systematic PubMed review of English-language articles published from 1982 to 2017 was performed using the following search terms: isotretinoin, 13-cis-retinoic acid, Accutane, retinoids, acitretin, surgery, surgical, laser, ablative laser, nonablative laser, laser hair removal, chemical peel, dermabrasion, wound healing, safety, scarring, hypertrophic sc...
Dermatologic Surgery, 2016
Schick and colleagues have performed a thorough well-designed study on the use of radiofrequency ... more Schick and colleagues have performed a thorough well-designed study on the use of radiofrequency (RF) for the treatment of axillary hyperhidrosis, a debilitating medical disorder with a marked effect on the quality of life. In this case, RF energy is delivered in an array of 5 · 5 noninsulated (unsheathed) needle electrodes with a diameter of 0.3 mm at varying depths of 3 and 2 mm in a 2-pass technique. Multiple treatments were necessary. At 6 months after the last treatment, subjective end points of Hyperhidrosis Disease Severity Scale and Dermatology Quality of Life Index were measured and objective gravimetric measurements (baseline vs postprovocation) were performed. Results showed that safety was well maintained with minimal downtime, and impressively an approximate 10-fold reduction in gravimetric readings and 90% subject survey satisfaction in this small sample size of patients, who had previously failed other medical therapies to control their excessive sweating.
Lasers in Surgery and Medicine, 2016
The aging process is commonly associated with skin laxity in the lower face and neck. Conventiona... more The aging process is commonly associated with skin laxity in the lower face and neck. Conventional surgery can correct this at least to some extent, but is invasive. Fractional high-intensity focused radiofrequency delivered to the dermis with insulated microneedles has recently attracted attention in facial rejuvenation. The present pilot study was designed to assess the efficacy of HiFR for skin laxity of the lower face and neck. Thirty-three patients (7 males, 26 females, age range 37-74 years) with mild to moderate skin laxity of the lower face/neck participated in the study. Three treatments were given at monthly intervals with protocols developed by the authors, three passes per session, at decreasing dermal depths for each pass. Histologic assessment of skin immediately after treatment was performed to identify the site and area of damage in the dermis. Clinical digital photography was taken at baseline and at 6 months after the final treatment session, based on which standardized computer measurement of improvement in the gnathion and cervicomental angles was the primary objective evaluation. A global assessment of improvement was graded by blinded assessors based on the photography. A telephone survey of patient satisfaction was performed at 12 months post-treatment. A significant post-treatment decrease in the cervicomental and gnathion angles was seen of 28.5° and 16.6°, respectively (P < 0.0001 for both). Histology immediately post-treatment showed a clear demarcated and roughly oval area of coagulation associated with the tip of the needle, confined to the dermis and not involving the epidermis. In the global assessment 81.8% of the patients achieved moderate or higher results, and 87% of patients were very satisfied or better. Downtime was minimal, lasting 3-4 days, and no persistent adverse events were recorded. Fractional HiFR proved safe and effective in the treatment of neck laxity in a large age range of patients, including the elderly. Lasers Surg. Med. 48:461-470, 2016. © 2016 Wiley Periodicals, Inc.
Journal of Drugs in Dermatology Jdd, Sep 1, 2006
Background and Objectives: Monopolar radiofrequency skin heating coupled with cryogen cooling of ... more Background and Objectives: Monopolar radiofrequency skin heating coupled with cryogen cooling of facial skin for skin tightening has been utilized on over 10,000 patients since 2002. In order to establish the actual rate and degree of side effects in our clinical experience, a retrospective chart review was performed. Study Design: Charts and clinical images of over 600 consecutive patient treatments between May 2002 and June 2006 using a monopolar radiofrequency device (Thermacool ® , Thermage, Haywood, CA) for skin tightening at the Maryland Laser, Skin and Vein Institute were retrospectively reviewed. The primary presentation for treatment was skin laxity of the lower face. Treatment was delivered with a 1-cm 2 standard tip at fluences of 81 to 124 J/cm 2 (level of 12.5 to 15), a 1-cm 2 "fast" tip at fluences of 62 to 109 J/cm 2 (level of 72.0 to 76.0), a 1.5-cm 2 "big fast" tip at fluences of 75 to 130 J/cm 2 (level of 61.5 to 65), and a 3-cm 2 "bigger" tip at equivalent fluences as each became available. As treatment algorithms evolved over 4 years, the algorithm of multiple passes at lower fluence associated with better clinical outcomes and greater patient acceptance has been adopted. Results: The most common immediate and expected clinical effects were erythema and edema lasting less than 24 hours, although 6 patients reported edema lasting for up to 1 week. There were no permanent side effects. In total, 2.7% of treatments resulted in temporary side effects, the most significant of which was a slight depression on the cheek (n = 1), which completely resolved within 3.5 months. Other side effects included localized areas of acneiform subcutaneous erythematous papules (n = 4) and a linear superficial crust (n = 1) with the original tip, all of which resolved within 1 week. One patient reported small erythematous subcutaneous nodules resolving in 17 days. Tenderness of the neck lasting from 2 weeks (n = 2) to 3 weeks (n = 1) was also reported. Conclusions: Our data, obtained in an office setting without injectable anesthetic or IV sedation, indicate that monopolar RF for skin tightening is a very safe procedure. The treatment algorithm and tips have evolved over several years leading to increased safety and efficacy. Side effects are infrequent, self-limited, and minor, comparing favorably to other nonablative devices utilized for facial rejuvenation.
Dermatologic Surgery, 2015
Pseudogynecomastia refers to benign male breast enlargement due to excess subareolar fat. Standar... more Pseudogynecomastia refers to benign male breast enlargement due to excess subareolar fat. Standard treatment is surgical excision under general anesthesia, liposuction, or a combination of both. The safety and efficacy of cryolipolysis was investigated for nonsurgical treatment of pseudogynecomastia. Enrollment consisted of 21 males with pseudogynecomastia. Subjects received a first treatment consisting of a 60-minute cryolipolysis cycle, followed by a two-minute massage, and a second 60-minute cycle with 50% treatment area overlap. At 60 days of follow-up, subjects received a second 60-minute treatment. Safety was evaluated by monitoring side effects and adverse events. Efficacy was assessed by ultrasound, clinical photographs, and subject surveys. Surveys revealed that 95% of subjects reported improved visual appearance and 89% reported reduced embarrassment associated with pseudogynecomastia. Ultrasound showed mean fat layer reduction of 1.6 ± 1.2 mm. Blinded reviewers correctly identified 82% of baseline photographs. Side effects included mild discomfort during treatment and transient paresthesia and tenderness. One case of paradoxical hyperplasia (PH) occurred but likelihood of PH in the male breast is not believed to be greater than in any other treatment area. This study demonstrated feasibility of cryolipolysis for safe, effective, and well-tolerated nonsurgical treatment of pseudogynecomastia.
Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology, 2008
Acne is a very prevalent skin disorder, and several devices, such as blue light, pulsed dye laser... more Acne is a very prevalent skin disorder, and several devices, such as blue light, pulsed dye laser, diode laser, LED, RF and pulsed light systems, have been reported to have varying degrees of efficacy for treatment. Photopneumatic therapy (PPX) is a novel technology that combines pneumatic energy with a broadband light source to manipulate the optical characteristics of the skin. A vacuum suction raises target structures in the dermis closer to the surface of the skin prior to exposure, allowing for more efficient energy transmission. This study tested the hypothesis that a combination of pulsed light and suction would affect sebaceous plugging within diseased pilosebaceous apparati at a histological level, resulting in the rapid clearance of acne lesions. Eight individuals were treated with PPX once per week for a total of five treatments. Punch biopsies of the treated areas were obtained just after the first exposure, just before the third exposure and immediately after the fifth ...
Journal of drugs in dermatology : JDD, 2006
The use of thermal heating in microscopic zones is generically termed "microrejuvenation.&qu... more The use of thermal heating in microscopic zones is generically termed "microrejuvenation." The objective of this study was to evaluate the benefits of using a novel 1440-nm Nd:YAG laser (Affirm, Cynosure, Westford, MA) with a novel approach for microscopic heating. This device utilizes a microarray of lenses delivering a 10-mm beam as hundreds of high-fluence beamlets interspersed with a relatively uniform low-fluence background irradiation. Forty subjects (N = 40) at 2 study sites presenting with superficial rhytides and other symptoms of photoaging or scars received 3 treatments at 4-week intervals using a T-250 lens array. Total fluence ranged from 3.0 to 7.0 J/cm2. Zimmer air cooling was used for all treatments. No topical anesthetic was required. The most common immediate and expected clinical effects were erythema and edema lasting less than 24 hours, although 6 patients reported edema lasting for up to 1 week. There were no permanent side effects. In total, 2.7% of ...
Lasers in Surgery and Medicine, 2015
Lichen amyloidosis is characterized by amyloid deposition in the papillary dermis, presenting cli... more Lichen amyloidosis is characterized by amyloid deposition in the papillary dermis, presenting clinically with intensely pruritic hyperkeratotic papules. Various treatment modalities have been used but the results are generally unsatisfactory. Several studies show that non-ablative fractional lasers can be used to treat depositional diseases due to their capability of inducing transepidermal elimination of the dermal content. To investigate the efficacy and safety of a non-ablative fractional 1,550 nm Yttrium/Erbium fiber laser for the treatment of lichen amyloidosis. Ten subjects with a clinical and histological diagnosis of lichen amyloidosis were treated with fractional non-ablative laser using a 7-cm tip, with the parameter of 30 mJ/cm(2) and 1,000 microscopic treatment zones (MTZ)/cm(2) for three sessions at 4-week intervals. Clinical improvement (in terms of global improvement score, brownish/hyperpigmentation, thickness, and number of papules) was evaluated using a quartile grading scale at baseline, and 4, 12, and 24 weeks after the last treatment. Itch score and subjective satisfaction rates were also assessed. Adverse events were recorded, and pain was scored using a visual analog scale (VAS). Histologic changes were observed using standard staining with hematoxylin and eosin, as well as special stains of alkaline congo red and crystal violet at baseline and 4 weeks after treatment. At 4 and 24 weeks after treatment, the lichen amyloid lesions had statistically significantly improved in all aspects compared to baseline (P = 0.01 and P = 0.016, respectively; Wilcoxon signed-rank test). However, partial recurrence was reported in 2 out of 10 subjects. All subjects rated itching symptom significantly improved after only the first treatment (P < 0.05). Minimal side effects were recorded, including a burning sensation, transient erythema, and edema. Histological evaluation demonstrated decreased epidermal thickness, and degeneration and shrinkage of amyloid material deposition in the papillary dermis. There was no amyloid material deposition noted in two out of eight histopathology studies. The non-ablative fractional 1,550 nm Ytterbium/Erbium fiber laser is safe and effective for the treatment of lichen amyloidosis. However, larger controlled studies are required to further establish the efficacy of this treatment. Lasers Surg. Med. 47:222-230, 2015. © 2015 Wiley Periodicals, Inc.
The effect of sulfur mustard (SM, bis-(2-chloroethyl) sulfide) on intracellular free Ca-÷ concent... more The effect of sulfur mustard (SM, bis-(2-chloroethyl) sulfide) on intracellular free Ca-÷ concentration ((Ca2]i) was studied in vitro using the clonal mouse neuroblastoma-rat glioma hybrid NG108-15 and primary normal human epidermal keratinocyte (NHEK) cell culture models. SM depletes cellular glutathione (GSH) and thus may inhibit GSH-dependent Ca 2 ÷-ATPase (Ca2* pump), leading to a high (Ca 2-]i and consequent cellular toxicity. Following 0.3 mM SM exposure, GSH levels decreased 20-34% between 1-6 hr in NG108-15 cells. SM increased [Ca 2 +]I, measured using the Ca 2 ÷-specific fluorescent probe Fluo-3 AM, in both NG108-15 cells (10-30% between 2-6 hr) and NHEK (23-30% between 0.5-3 hr). Depletion of cellular GSH by buthionine sulfoximine (I mM), a specific GSH biosynthesis inhibitor, also increased (Ca2*, (88% at 1 hr) in NHEK, suggesting that GSH depletion may lead to increased (Ca2*] 1. Calcium, localized cytochemically with antimony, accumulated in increased amounts around mitochondria and endoplasmic reticula, in the cytosol, and in particular in the euchromatin regions of the nucleus beginning at 6 hr after 0.3 mM SM exposure of NG108-15 cells.
Medical Laser Application, 2008
Acne is a very prevalent skin disorder and several devices (such as blue light, pulsed dye laser,... more Acne is a very prevalent skin disorder and several devices (such as blue light, pulsed dye laser, diode laser, LEDs, RF, and pulsed light) have been reported to have varying degrees of efficacy for treatment. Pulsed light treatments have been used both alone and in combination with other modalities to rapidly reduce active acne. Photopneumatic therapy is a novel technology
Seminars in Cutaneous Medicine and Surgery, 2008
Acne is a very prevalent skin disorder, affecting more than 85% of adolescents and often continui... more Acne is a very prevalent skin disorder, affecting more than 85% of adolescents and often continuing into adulthood. Active acne and its sequelae, especially permanent scarring, may cause longstanding psychological or emotional harm in patients. Novel and promising treatments with laser/light devices (such as blue light, red light, pulsed dye laser, infrared lasers, light-emitting diodes, and pulsed light) have been reported to have varying degrees of efficacy for treatment. The authors compiled a summary of evidence-based literature on laser/light treatment for acne to assist clinicians to more appropriately identify treatment options, should they choose to supplement current medical antiacne therapies.
Seminars in Cutaneous Medicine and Surgery, 2007
Sclerotherapy is the systematic, targeted elimination of intracutaneous and subcutaneous varicose... more Sclerotherapy is the systematic, targeted elimination of intracutaneous and subcutaneous varicose, reticular, telangiectasias by the injection of a locally irritating chemical substance, called a sclerosant. The endpoint of this process is functionally analogous to surgical removal of a vein. However, regardless of the best of intentions, complications can and will occur with enough sclerotherapy treatments. Complications resulting from sclerotherapy can be divided into the following categories for ease of explanation: (1) frequent but transient, (2) rare but self-limited, and (3) rare but major. This article will focus on select complications in sclerotherapy, review the most common complications observed, and discuss how to minimize these in daily practice.
Lasers in surgery and medicine, 2015
Persistent post-acne erythema is one of the most common aesthetic sequelae to arise after active ... more Persistent post-acne erythema is one of the most common aesthetic sequelae to arise after active acne resolves. The treatment remains challenging due to lack of effective laser modalities. To evaluate the safety and efficacy of a low-fluence 585 nm Q-switched Nd:YAG laser for the treatment of post-acne erythema. Twenty-five patients with post-acne erythema were treated with a low-fluence Q-switched Nd:YAG laser using the 585 nm Gold Toning™ handpiece (5 mm spot size, 5-10 ns, 0.30-0.55 J/cm(2) , 2-4 passes) for three sessions at 2-week intervals. Erythema lesion (macules) count, inflammatory acne (papules, pustules) count, erythema index, degree of post-acne erythema and overall improvement in post-acne erythema and acne scar were assessed at baseline, every 2 weeks and 6 weeks after the last treatment. Subjective degrees of satisfaction were also evaluated. Adverse events were recorded and pain was scored using a visual analog scale (VAS). At 6 weeks after 3 sessions of laser treat...
Seminars in cutaneous medicine and surgery, 2005
The use of endovenous procedures to eliminate saphenous and primary branch reflux has been growin... more The use of endovenous procedures to eliminate saphenous and primary branch reflux has been growing exponentially over the last few years. Although initially developed by dermatologic surgeons, the technique has been embraced by many other specialties including radiology, vascular surgery and anesthesiology. Radiofrequency energy was the first used in 1999 for endovenous ablation. More recently, laser technology targeting hemoglobin (810 nm, 940 nm & 980 nm) and water (1320 nm) have been developed to quickly and effectively treat saphenous reflux, with minimal side effects. The placement of peri-vascular anesthesia, using the tumescent technique, has further streamlined these procedures. The purpose of this article is to review our experience and outline advantages and disadvantages of the various techniques available.