Status Report From the American Acne & Rosacea Society on Medical Management of Acne in Adult Women, Part 2: Topical Therapies

The treatment of AV in adult women may incorporate any of the topical therapies used to treat AV in adolescents, especially as studies encompass both the adolescent and adult age ranges. This is especially true with mixed pattern AV, which is the predominant presentation in participants enrolled in clinical trials with topical therapies, especially of moderate severity.

Herein we provide a summary of the topical therapies that have been evaluated by post hoc analyses of data from pivotal studies in adult women with AV.

Adapalene Gel 0.3%

Adapalene exhibits retinoid activity with efficacy in reducing inflammatory and comedonal AV lesions shown with both 0.1% and 0.3% concentrations.^33-35 Post hoc analyses of 2 pivotal RCTs of patients with facial AV showed that adapalene gel 0.3% once daily (n=74; mean age, 27.2 years) was superior to vehicle once daily (n=43; mean age, 25.2 years) in both mean and median percentage reductions of comedonal, inflammatory, and total lesions in women 18 years and older who were treated for 12 weeks; the difference in mean percentage lesion reduction from vehicle for total AV lesions was statistically significant at 12 weeks (P=.045).²⁶ Adapalene gel 0.3% produced a favorable skin tolerability profile similar to adapalene gel 0.1%, with the most common adverse reactions being discomfort and dryness.

Advantages of topical retinoid therapy in adult women with facial AV are reduction in postinflammatory hyperpigmentation and therapeutic modulation of chronic photodamage (eg, fine lines, rough texture, dyschromia).^29,36,37 Disadvantages include signs and symptoms of cutaneous irritation, although this tends to occur less frequently on facial skin with adapalene gel 0.3% as compared to other topical retinoids that exhibit comparable efficacy.^33-37 Topical retinoid therapy on the anterior neck and upper chest should be used cautiously, as these anatomic sites appear to be more prone to cutaneous irritation.

Dapsone Gel 5%

Dapsone is a sulfone antimicrobial and anti-inflammatory agent that has been shown to be effective, safe, and well tolerated in the treatment of AV in a topical 5% formulation.^38,39 A post hoc analysis of pivotal 12-week trial data suggested that dapsone gel 5% twice daily produced greater AV reductions in females compared to males; no gender differences were noted in adverse effects, which were low in frequency.³⁹ A separate subgroup analysis compared outcomes among adult women (≥18 years of age; n=434) and adolescent girls (12–17 years of age; n=347) treated with dapsone gel 5%.¹¹ The proportion with no or minimal acne based on the Global Acne Assessment Score at week 12 was greater in adult women (53.5%) versus adolescent girls (45.3%, P=.022), with significantly greater percentage reductions in both noninflammatory (P<.0001) and total lesion counts (P=.0008) observed in the adult group. Percentage reductions in inflammatory lesions were similar in both groups. No major safety or tolerability issues or new safety signals were noted. Advantages of dapsone gel 5% are highly favorable tolerability and the perception of decreased oily skin in some participants.^38,39

Clindamycin Phosphate 1.2%–Benzoyl Peroxide 3.75% Gel

The combination formulation of CP 1.2%– BP 3.75% gel applied once daily has been shown to be effective, well tolerated, and safe for the treatment of facial AV, with a gender analysis noting an apparent greater efficacy in females.^40,41 A post hoc analysis from the 12-week pivotal study data in adult women aged 25 years and older showed a mean percentage change from baseline in inflammatory and noninflammatory lesion counts and the percentage of participants who achieved a 2-grade improvement by global assessment to be 68.7%, 60.4%, and 52.7% in actively treated participants (n=29), respectively, which was significantly superior to vehicle applied once daily (n=43; P=.019, P=.020, and P=.074, respectively).⁴² No relevant differences in tolerability were noted among treatment groups, and no participants discontinued therapy due to adverse events. Advantages of CP 1.2%–BP 3.75% gel are highly favorable skin tolerability and the perception of decreased oily skin in some participants.^41-43

Adapalene 0.1%–Benzoyl Peroxide 2.5% Gel

A meta-analysis of pooled data from 3 RCTs evaluated use of adapalene 0.1%–BP 2.5% gel applied once daily in adult women aged 25 years and older with facial AV (n=130) versus vehicle gel applied once daily (n=124).³⁰ The percentage of participants who achieved investigator global assessment ratings of clear or almost clear was 39.2% in actively treated participants versus 18.5% with vehicle (P<.001), and median percentage lesion reduction was approximately 30% greater in those treated with adapalene 0.1%–BP 2.5% gel versus vehicle gel. Tolerability and safety were favorable.

Other Agents

Topical azelaic acid (20% cream formulation, 15% gel formulation) has been suggested as a treatment option for adult women with AV, including patients with darker skin who are more prone to persistent hyperpigmentation.²⁹