Sequential Treatment with Triple Combination Cream and Intense Pulsed Light is More Efficacious than Sequential Treatment with an Inactive (Control) Cream and Intense Pulsed Light in Patients with Moderate to Severe Melasma (original) (raw)
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Nepal Journal of Dermatology, Venereology & Leprology, 2021
Introduction: Various studies explored the use of intense pulse light (IPL) therapy in treating melasma, but only a few randomized clinical trials have evaluated the combination of triple combination cream (TCC) with IPL so far. Objective: This study compared the efficacy and safety of the combination of IPL and triple combination cream with triple combination cream alone in treating melasma. Material and Methods: Sixty patients with melasma were enrolled in this assessor-blinded, parallel-group randomized controlled study. Thirty patients were treated with IPL (15J/cm2, two sessions at 2-week intervals) and TCC (Hydroquinone 2%, tretinoin 0.025%, fluocinolone acetonide 0.01%) at night and broad-spectrum sunscreen during day time whereas other groups received only TCC and broad-spectrum sunscreen. The median percentage reduction in melasma area and severity index (MASI) and physician’s global assessment scale was assessed at 12-week to determine the efficacy of the treatment. The in...
Clinical, Cosmetic and Investigational Dermatology
Background: Melasma is the most common pigmentary skin disorder, especially in females and those with darker complexion. The current study evaluated the safety and efficacy of a triple combination cream containing hydroquinone 4%+tretinoin 0.05%+fluocinolone acetonide 0.01% (Januluma ® cream produced by Janus Pharmaceutical Co, Tehran, Iran) in the treatment of melasma. Patients and methods: Twenty-two female volunteers (mean±standard deviation of age: 39.20±4.16 years) who fulfilled the eligibility criteria participated in this study after signing the informed consent. They were requested to apply the Januluma ® cream every night for 8 weeks. Modified melasma area and severity index (mMASI), skin lightness (L value), and severity of pigmentation (E value) by Visio Face, and skin biophysical parameters including pH, melanin index, erythema index, sebum, hydration, trans epidermal water loss, thickness and density of epidermis, and dermis (using 22 MHz ultrasonography) were measured before and 4 and 8 weeks after treatment. Also patients' satisfaction was assessed 4 and 8 weeks after treatment using visual analog score. Results: mMASI decreased significantly from 3.37 to 2.60 at week 4, and to 2.40 at week 8 (P-values=0.00 and 0.01, respectively). Also, E and L values improved significantly after 8 weeks of treatment (P=0.01 and 0.00, respectively). Skin melanin index decreased from 237.49 AU to 196.30 AU at week 8 (P=0.01). Also echo density of dermis increased significantly after 8 weeks of treatment (P=0.029). Almost all participants experienced some degrees of pruritus, scaling, and erythema, esspecially during the first month of application, which were generally mild and tolerable. The mean satisfaction of patients with the treatment was 6.77. Conclusion: The triple combination formula was reasonably safe and effective for treatment of melasma in Middle Eastern patients.
Efficacy and safety of a new triple-combination agent for the treatment of facial melasma
Cutis, 2003
Treatment of melasma, a hyperpigmentation disorder, remains a challenge. The primary objective of two 8-week, multicenter, randomized, investigator-blind studies was to compare the efficacy and safety of a hydrophilic cream formulation containing tretinoin 0.05%, hydroquinone 4.0%, and fluocinolone acetonide 0.01% (RA+HQ+FA) with the dual-combination agents tretinoin plus hydroquinone (RA+HQ), tretinoin plus fluocinolone acetonide (RA+FA), and hydroquinone plus fluocinolone acetonide (HQ+FA). All agents had the same drug concentration and vehicle. A total of 641 adult patients, predominantly female, with moderate to severe melasma and Fitzpatrick skin types I through IV, were randomized to the various treatment groups. Due to the similarity of the study designs, the results of the 2 studies were combined and are reported here. The primary efficacy analysis involved the proportion of intent-to-treat patients in each treatment group whose condition had completely cleared by week 8. Th...
Clinical drug investigation, 2015
This study aimed to determine the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin (FAHT) cream for the treatment of moderate and severe facial melasma. The primary objective was assessment of clinical efficacy, instrumental measured efficacy, and integral therapeutic efficacy at the end of weeks 4 and 8. A total of 233 subjects were randomly allocated (1:1 ratio) to receive topically administered FAHT cream (n = 117) or placebo (n = 116) once nightly for 8 weeks. Observed side effects were documented throughout. In the per protocol set (PPS; those subjects who met all requirements of the protocol), the integral therapeutic efficacy rate of FAHT cream on moderate and severe melasma was 68.57 % (vs. placebo, 0.94 %), the clinical effective rate of FAHT cream was 74.29 % (vs. placebo, 0.94 %), and the instrumental measure efficacy of FAHT cream was 71.43 % (vs. placebo, 6.60 %). The difference in efficacy between the two groups was statistically significant (...
Clinical, Cosmetic and Investigational Dermatology, 2019
Background: Melasma is a common benign acquired pigmentary dermatosis due to a disorder in the function of the melanogenesis process. Although several treatments are currently used, it remains a great challenge. Aim: The aim of this study is to compare the efficacy of intradermal injected tranexamic acid (TA) vs hydroquinone (HQ) cream in the treatment of melasma. Materials and methods: In this prospective split face controlled clinical trial, 49 patients were randomly divided into two groups of A (24 persons) and B (25 persons). Patients received TA intradermal injections every 2 weeks on the right side of the face with a concentration of 4 mg/ mL in group A and a concentration of 10 mg/mL in group B. The left side in both groups was treated twice daily with topical 4% HQ cream, and treatment continued for 12 weeks in both groups. Melasma Area and Severity Index (MASI) scores were measured for each side of the face at baseline and at weeks 4, 8, 12, and 24. SPSS, version 22, P<0.05, was used for data analysis. Results: Forty-one patients (21 in group A and 20 in group B) completed the study. The MASI score in the 12th week significantly decreased compared to the baseline for group A, group B, and HQ cream. However, no statistically significant difference was observed between the MASI score of patients in groups A and B. Also, the comparison of TA at the concentration of 4 mg/ mL compared to the 4% HQ cream showed that the MASI scores in the eighth week (P=0.02) and the 12th week (P=0.02) were significantly less in the HQ group. However, no significant difference was observed between the MASI score changes in Group B (10 mg/mL) and the 4% HQ group. Also, patients in group A had higher satisfaction than patients in group B (P=0.001). Conclusion: Injection of TA intradermally can be an effective treatment for melasma.
Efficacy of intradermal injected tranexamic acid vs intense pulse light in the treatment of melasma
The Professional Medical Journal
Objective: To compare the efficacy of Intradermal Tranexamic acid and Intense Pulse Light (IPL) in the treatment of melasma. Study Design: Interventional study. Setting: Department of Dermatology, HIT Hospital. Period: Dec 2022 to May 2023. Material & Methods: 88 Female aged between 18 and 50 with melasma were included in this study. Participants who have used topical treatments for melasma, with any medical illness or bleeding disorder, history of photosensitivity were excluded. Participants of ITA group received intradermal tranexamic acid in a concentration of 4mg/ml monthly for four sessions. While the participants of IPL group were treated fortnightly for four sessions. mMASI was used to calculate the severity of melasma before and 2 weeks after last session. Patients perception of treatment efficacy and side effects were noted in each group. SPSS-28 was used. Paired t- test and independent t- test was applied to compare the effectiveness of both treatment modalities. A p-value...
Serbian Journal of Dermatology and Venereology, 2019
Introduction. Melasma is a common skin pigmentation disorder affecting a patient’s life psychologically and socially. Topical medications or lasers can have temporary and limited therapeutic effects on melasma. Material and Methods. This study is a prospective clinical trial comparing therapeutic effects of oral Tranexamic acid (TXA) and topical Hydroquinone (HQ) cream. A total number of 69 patients were examined. During the study, 10 patients failed to appear for the follow-up and 59 of them completed the trial. The patients were also divided randomly into two groups. Group A received TXA capsule 250 mg every 12 hours and group B received 4% topical HQ cream day and night. The patients from both groups were treated for 3 months. Melasma Area and Severity Index (MASI) scores were then calculated at the baseline, 4 weeks, and 12 weeks into the treatment and 3 months after the end of intervention. Results. MASI baseline, 4 weeks,12 weeks, and 24 weeks in TXA group were 21.66, 13.69, 9...
Berkala Ilmu Kesehatan Kulit dan Kelamin
Background: Melasma is a hyperpigmentation disorder that affects the quality of life, especially in women. Hydroquinone has remained the mainstay of melasma treatment. However, its safety for long-term usage became a great concern. Combination therapy, such as niacinamide and kojic acid, can be used as an alternative melasma treatment due to different mechanisms of action and synergism. Purpose: The aim of this study was to compare the efficacy and safety of a combination of 4% niacinamide and 4% kojic acid (N-K) vs. 4% hydroquinone (HQ) in epidermal melasma. Methods: This was a randomized, double blind, clinical study on 13 female epidermal melasma patients at the Cosmetic Dermatology Outpatient Clinic of Dr. Hasan Sadikin Hospital, Bandung. Patients received two creams, a combination of N-K and HQ, for split-face therapy, regardless of the sides of the face. All patients were followed up at 4 and 8 weeks. The clinical efficacy was assessed for skin lightening effects using a spect...