Efficacy and Safety of Subantimicrobial Dose, Modified-Release Doxycycline 40 mg Versus Doxycycline 100 mg Versus Placebo for the treatment of Inflammatory Lesions in Moderate and Severe Acne: A Randomized, Double-Blinded, Controlled Study.

INTRODUCTION: Routine use of doxycycline (DC) 100 mg for the treatment of moderate to severe acne may be associated with gastrointestinal adverse events (AEs), thus potentially impacting patient adherence, and antibiotic resistance. This study evaluated the safety and efficacy of subantimicrobial, modified-release (MR) DC 40 mg compared to DC 100 mg and to placebo for the treatment of inflammatory lesions in moderate and severe acne. METHODS: 662 subjects aged 12 years or older with moderate to severe acne received subantimicrobial, MR-DC 40 mg tablets, DC 100 mg capsules, or placebo once daily for 16 weeks. RESULTS: MR-DC 40 mg was superior to placebo in the mean reduction of the number of inflammatory lesions, median percent reduction in inflammatory and total lesions, and success rate. MR-DC 40 mg was also comparable to DC 100 mg in the reduction of the number of inflammatory lesions, and percent reduction of total lesions. Incidence of drug-related AEs for MR-DC 40 mg was similar to placebo and was markedly smaller compared to DC 100 mg. DISCUSSION: MR-DC 40 mg demonstrated comparable efficacy and superior safety to DC 100 mg in the treatment of moderate to severe inflammatory acne.

Preadolescent moderate acne vulgaris: a randomized trial of the efficacy and safety of topical adapalene-benzoyl peroxides.

OBJECTIVE: Evaluate the efficacy and safety of adapalene 0.1%-benzoyl peroxide 2.5% gel (adapalene-BPO) in patients 9-11 years old with acne vulgaris.
METHODS: Enrolled subjects were male or female, with a score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale. Subjects were randomized to receive adapalene-BPO or vehicle once daily for up to 12 weeks. Efficacy was evaluated by success rate (percentage of subjects rated "clear" or "almost clear") at each visit, median percentage changes from baseline in total, inflammatory and non-inflammatory lesion counts at each visit, the Children's Dermatology Life Quality Index (C DLQI) at baseline and week 12, and the Parent Assessment of Acne at week 12. Safety was assessed through evaluations of adverse events (AEs) and local tolerability [erythema, scaling, dryness, and stinging/burning on scales ranging from 0 (none) to 3 (severe)].
RESULTS: A total of 142 subjects were randomized to adapalene-BPO and 143 to vehicle. At study endpoint (week 12), adapalene-BPO was significantly superior to vehicle regarding treatment success (49.3% vs 15.9%, respectively), and regarding percentage reduction in total lesion counts (68.6% vs 19.3%), inflammatory (63.2% vs 14.3%), and non-inflammatory lesion counts (70.7% vs 14.6%) (all P<.001). More subjects using adapalene-BPO reported that their acne had no effect on their quality of life, and parents noted that their child's acne significantly improved. Adapalene-BPO was well tolerated, with mean tolerability scores less than 1 (mild).
CONCLUSIONS: In preadolescents with acne, adapalene-BPO leads to significantly superior treatment success and lesion count reduction compared to vehicle.

The efficacy of adapalene-benzoyl peroxide combination increases with number of acne lesions.

BACKGROUND: There is no direct correlation between acne severity and lesion numbers and patients with moderate acne may present with varying lesion counts. The fixed-dose adapalene 0.1%-benzoyl peroxide (BPO) 2.5% combination gel is an efficacious and safe acne treatment. OBJECTIVE: We sought to evaluate whether the benefit of adapalene-BPO relative to vehicle varies with baseline lesion counts. METHODS: Data were pooled from 3 randomized, double-blind, controlled studies, which compared efficacy in 4 treatment groups (adapalene-BPO, adapalene, BPO, and the gel vehicle). Three lesion count subgroups (Low, Mid, and High) were defined based on the number of total, inflammatory, or noninflammatory lesion at baseline. Efficacy of each treatment and benefit of each treatment relative to vehicle were evaluated on the entire population and in all lesion count subgroups. Safety was assessed by local tolerability score and adverse events. RESULTS: Adapalene-BPO provided significant benefit relative to vehicle and monotherapies on the entire population and in all lesion count subgroups (P < .05). At study end point, the benefit of adapalene-BPO relative to vehicle was greatest in the High subgroup, suggesting that patients with the highest baseline lesion counts contributed the most to the treatment benefit observed in the entire population. This effect was only observed with adapalene-BPO and not with monotherapies. Higher baseline lesion counts did not lead to more related adverse event or worse tolerability score for adapalene-BPO. LIMITATION: These results were generated from clinical trials. Results in clinical practice could differ. CONCLUSION: The relative benefit of adapalene-BPO increases with higher lesion counts at baseline.

Adapalene 0.1% lotion in the treatment of acne vulgaris: results from two placebo-controlled, multicenter, randomized double-blind, clinical studies.

BACKGROUND: Acne vulgaris is a common chronic skin disease affecting roughly 15 percent of the general population and up to 85 percent of adolescents and young adults. Adapalene, a synthetic naphthoic acid derivative with retinoid activity, has demonstrated good clinical efficacy in the treatment of acne if used with full compliance. OBJECTIVES: To evaluate the efficacy and assess safety of a new adapalene formulation, adapalene 0.1% lotion, versus the lotion vehicle in subjects with acne vulgaris. METHODS: Subjects were randomized to receive either adapalene 0.1% lotion or its vehicle once daily for 12 weeks in two multicenter, randomized, vehicle-controlled, double-blind, parallel group studies. Efficacy was evaluated using two co-primary endpoints: Investigator Global Assessment (IGA) of success rate (defined as the proportion of subjects who achieved at least a two point reduction, on a 5-point scale, from baseline to week 12 in IGA score); and the absolute change from baseline to week 12 in total, inflammatory and non-inflammatory lesions. Signs of local skin irritation and routine clinical safety parameters were evaluated throughout both studies. RESULTS: In total, 2,141 subjects were included in the two studies: 1,068 patients received adapalene 0.1 percent lotion and 1073 received the vehicle. In both studies, adapalene 0.1% lotion was shown to be significantly more effective than its vehicle in improvement in the IGA success rate. Adapalene 0.1% lotion was also significantly superior to its vehicle in all three lesion reduction measures: total, inflammatory and non-inflammatory. Reports of application site skin irritation in the adapalene 0.1% lotion treatment group were transient and mild or moderate in severity, with only a few being severe. Additionally, according to patient surveys, the lotion formulation was found to be easily spreadable, easily absorbed and pleasant to use. CONCLUSION: Adapalene 0.1% lotion used once a day for 12 weeks is effective and well tolerated in the treatment of acne vulgaris.