Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Impact of Gender and Race on Efficacy and Safety

Background: There has been an increasing interest in gender and racial differences both in the pathogenesis and treatment of acne vulgaris (acne), and postinflammatory hyperpigmentation (PIH) is a major concern in patients of color. Female acne patients report more anxiety and depression with acne improvement positively influencing Quality of Life (QoL) than their male counterparts, and there are differences in acne presentation. The first lotion formulation of tretinoin was developed using novel polymeric emulsion technology to provide an important alternative option to treat these acne patients, especially those who may be sensitive to the irritant effects of other tretinoin formulations. Objective: To determine the impact of gender and race on the efficacy and safety of tretinoin 0.05% lotion in treating moderate or severe acne. Methods: Post hoc analysis of 2 multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate-to-severe acne. Subjects (aged 9 to 58 years, N=1640) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Quality of Life was assessed using the validated Acne QoL scale. Safety, adverse events (AEs), cutaneous tolerability, and hypo-/hyper-pigmentation (using a 4-point scale where 0=none and 3=severe) were evaluated at each study visit. Results: At week 12, mean percent reduction in inflammatory lesion counts were 56.9% and 53.4% respectively in female and male patients compared with 47.1% and 39.4% with vehicle (P≤0.001), with females statistically significant to males at week 8 [P=0.026]). Mean percent reduction in noninflammatory lesion counts in females and males were 51.7% and 46.1% respectively, compared with 34.9% and 29.7% with vehicle (P<0.001), with females statistically significant to males at week 12 (P=0.035). Treatment success was achieved by 23.6% and 16.1% of female and male patients treated with tretinoin 0.05% lotion by week 12 (P≤0.001 vs vehicle) with females statistically significant compared with males (P=0.013). Significant differences in inflammatory lesion count reductions were reported in Caucasian patients from week 8, and Black African/American male patients at week 12. Only male patients reported significant differences in both races in terms of noninflammatory lesions, and only Caucasian patients reported significant differences in treatment success. Female patients treated with tretinoin 0.05% lotion had statistically significant improvements in each Acne QoL domain (except role-social) compared with vehicle. Improvements in QoL in male subjects were only statistically different for acne symptoms. Tretinoin 0.05% lotion was well-tolerated in both genders. There were more treatment-related AEs in the female subpopulation, with a significantly greater incidence of skin dryness (P=0.006), that was more common in the younger Caucasian females. Conclusions: Tretinoin 0.05% lotion has been shown to be effective and well tolerated in moderate-to-severe acne. Treatment was significantly more effective in females than males. Tretinoin 0.05% lotion was well tolerated by both genders, although there was a higher incidence of treatment-related AEs, especially skin dryness, in females. There were racial and gender differences in QoL and beneficial effects on PIH in those patients most at risk. J Drugs Dermatol. 2019;18(11):1128-1138.

Treatment of Facial Acne Scarring With Fractional Carbon Dioxide Laser in Asians, a Retrospective Analysis of Efficacy and Complications.

BACKGROUND: Fractional carbon dioxide (CO2) laser resurfacing unites the idea of fractional photothermolysis with an ablative 10,600-nm wavelength. This technology permits effective treatment of acne scarring, with shorter recovery and a decreased side effect profile as compared to traditional CO2 laser resurfacing. OBJECTIVE: The aims of this study were to study the efficacy and safety of fractional CO2 laser for acne scars in Asian patients. METHODS: This was a retrospective study of all patients treated with the fractional CO2 laser for facial acne scarring between January 2, 2008, and December 31, 2010, at the National Skin Centre, Singapore. Data reviewed included sex, age, and severity of acne, type of scarring, previous treatment history, frequency of treatments, adverse events, and efficacy. RESULTS: Two hundred and ten fractional CO2 laser treatments for facial acne scars were performed on 107 patients (65 men and 42 women, Fitzpatrick skin Types II to V) during the study period. Sixteen of 107 patients experienced (15.0%) adverse events. The adverse events include hyperpigmentation (6.4%), blistering (4.0%), crusting (2.9%), aggravation of inflammatory acne lesions (1.7%), and scarring (0.6%). There were no reported side effects of hypopigmentation, bacterial or viral infection. Follow-up results after final laser treatment showed that 66.4% of patients reported Grade 1 skin texture improvement, that is, <25% (n = 71); 30.0% had Grade 2 improvement, that is, 25% to 50% improvement (n = 31); 3.7% had Grade 3 improvement, that is, 51% to 75% improvement (n = 4); and 0.9% had Grade 4 improvement, that is, >75% improvement (n = 1). CONCLUSION: The study demonstrated the efficacy and safety of a fractional CO2 laser in the treatment of acne scars in Asian. Future studies are required to establish optimum treatment parameters and achieve better clinical results.

[Analysis of the toll-like receptor 2 Arg753Gln gene polymorphisms of acne patients of Gan-depression induced qi stagnation syndrome and damp-heat in the interior syndrome].

OBJECTIVE: To study the toll-like receptor 2 (TLR2) Arg753Gln gene polymorphisms of acne patients of Gan-depression induced qi stagnation syndrome and damp-heat in the interior syndrome, thus laying the foundation for genetics studies on its occurrence. METHODS: The distribution and the frequency of allelic genes were studied in 75 acne patients of damp-heat in the interior syndrome, and 87 acne patients with Gan-depression induced qi stagnation syndrome, as well as 70 healthy subjects (as the normal control group) using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) technique. RESULTS: There was significant difference in the frequency of the genotype Arg/Gln + Gln/Gln in the TLR2 Arg753Gln genetic polymorphisms [26. 44% (23/87) in Gan-depression induced qi stagnation syndrome, 41.33% (31/75) in damp-heat in the interior syndrome, and 12.86% (9/70) in the normal control group] (P < 0.05). CONCLUSION: The existence of 753Gln allele in the Arg753Gln of TLR2 increased the onset risk of acne patients of Gan-depression induced qi stagnation syndrome and damp-heat in the interior syndrome.

Use of intense pulse light for acne vulgaris in Indian skin--a case series.

BACKGROUND: Intense pulse light (IPL) has become extremely popular in Indian cosmetology circles. Yet, literature is silent on its effect in heavily melanized skin. OBJECTIVE: A descriptive study to gauge the effect of IPL on acne vulgaris in Indian patients done in a tertiary care center in south India. MATERIALS AND METHODS: Patients with moderate to severe acne vulgaris were given a maximum of five sittings of IPL treatment. Lesion counts were performed and photographs compared before and after treatment. RESULTS: IPL was offered to 10 patients with acne vulgaris. Two patients dropped out, seven patients had a good response after a mean of 3.4 sittings; 87.5% patients expressed satisfaction with the procedure. No adverse effects were noted. CONCLUSION: IPL serves a useful role in the treatment of acne vulgaris and could reduce treatment costs and pill burden. There is no increased risk of side effects with IPL on Indian skin with standard care.

The effects of culture, skin color, and other nonclinical issues on acne treatment.

The effective and safe treatment of acne vulgaris often is affected by individual patient characteristics, including skin color and cultural background. Skin of color is especially prone to hyperpigmentation, both from lesions and from irritating therapy. Clinicians also should be aware of cultural attitudes and folk remedies that may adversely affect dermatologic conditions such as acne.

Laser therapy in black skin.

This article provides a systematic overview of laser, light, and other energy devices for patients of African descent. It also reviews complications in skin of color and some treatment options for these adverse events.

Treatment of facial acne papules and pustules in Korean patients using an intense pulsed light device equipped with a 530- to 750-nm filter.

BACKGROUND: A rising number of laser- or light-based therapies are addressing the need for effective acne treatments with minimal downtime. OBJECTIVE: The purpose of this study is to evaluate an intense pulsed light (IPL) equipped with a 530- to 750-nm filter for inflammatory acne treatment. PATIENTS AND METHODS: Thirty female patients (mean age, 25.7 years) with mild-to-moderate acne were enrolled. While using benzoyl peroxide (BP) gel, one side of the face was treated with the PR filter (acne filter) of the IPL. RESULTS: All patients experienced the reduction of inflammatory lesion counts in both sides of face. There was no significant difference between IPL-treated and untreated sides of the face for mean papule plus pustule counts, 3 weeks after three sessions. As to red macules, 63% were good or excellent on the laser-treated side compared to 33% on the untreated side. Improvement of irregular pigmentation and skin tone was detected on the laser-treated side than the untreated side. CONCLUSION: This new wavelength band of IPL system was safe and effective in improving acne red macules, irregular pigmentation, and skin tone but did not affect inflammatory acne lesion counts on the skin of Asian persons.

A comparative study of intense pulsed light alone and its combination with photodynamic therapy for the treatment of facial acne in Asian skin.

BACKGROUND AND OBJECTIVES: The reaction to intense pulsed light (IPL) on Asian skin often differs from that on Caucasian skin. The study reported herein evaluated the effect on acne vulgaris of IPL alone and when IPL was combined with photodynamic therapy (PDT) using topical methyl aminolevulinate (MAL) in Asians. STUDY DESIGN/MATERIALS AND METHODS: Thirty Chinese subjects with phototypes IV or V and moderate acne were enrolled for a randomized, half-facial treatment study with IPL alone, IPL with PDT, or as controls. Sixteen percent MAL cream was applied to half of the face 30 minutes before treatment in the PDT group. The IPL was provided by the Ellipse Flex system (Danish Dermatologic Development, Denmark), which emitted wavelengths of 530 to 750 nm. The subjects were treated four times at 3-week intervals. Single passes of double pulses with a 10 milliseconds delay and a pulse duration of 2.5 milliseconds were used. The assessment of inflammatory and non-inflammatory acne lesions by two blinded investigators was based on standardized photographs that were taken before each treatment, and at 4 and 12 weeks after the final treatment. RESULTS: Twenty-three patients completed the study. The mean reduction of the inflammatory lesion count was 53% in the PDT group, 22% in the IPL group, and 72% in the control group at 4 weeks, and 65% in the PDT group, 23% in the IPL group, and 88% in control group at 12 weeks. The mean clearance of non-inflammatory lesions was 52% in the PDT group, 15% in the IPL group, and 14% in the control group at 4 weeks, and 38% in the PDT group and 44% in the IPL group at 12 weeks, when and an increase of 15% was noted in the control group. Most patients experienced a reduction of inflammatory lesions that was not statistically significant on the PDT-treated side (P = 0.06) or the IPL-treated side (P = 0.82) at 12 weeks after treatment. Pretreatment with MAL resulted in a better clearance of inflammatory acne than IPL alone. There were no statistically significant differences between the intervention groups and the control group in the mean reduction of inflammatory lesions. Significant reductions of non-inflammatory lesions were observed in the MAL-PDT group (38%, P = 0.05) and IPL groups (43%, P = 0.00) 12 weeks after treatment. Twenty-five percent of the subjects in the PDT group withdrew because of intolerance to procedure-related discomfort. CONCLUSIONS: MAL-PDT using IPL and MAL in Asians did not lead to significant improvement of moderate inflammatory acne compared with the control group. However, there was a delayed effect on non-inflammatory lesions, with significant reductions in both the PDT and IPL groups. A proportion of patients could not tolerate the discomfort that was related to PDT despite the short MAL incubation.