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Acne Treatment Adapalene 0.3%/Benzoyl Peroxide 2.5% Shows Promise in Phase III Trial
Positive phase III results have been reported for adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO, Galderma Laboratories) topical gel, an antibiotic-free, investigational drug developed with a higher concentration of adapalene than that contained in Epiduo (adapalene 0.1%/benzoyl peroxide 2.5%) gel (Galderma).
The investigational drug is being evaluated for the treatment of acne by the FDA. The new data will be presented at the 73rd American Academy of Dermatology (AAD) annual meeting, to be held March 20–24 in San Francisco, California.
The multicenter, randomized, double-blind, parallel-group, vehicle- and active-controlled study assessed the efficacy and safety of 0.3% A/BPO in subjects with moderate or severe acne as well as in a subgroup of subjects with severe acne only. A total of 503 subjects (12 years of age and older) were involved in the study, with 251 (50%) subjects experiencing moderate acne, and the remaining 252 (50%) experiencing severe acne. The subjects were randomly assigned to apply 0.3% A/BPO, 0.1% A/BPO, or vehicle gel once daily for 12 weeks. The co-primary efficacy endpoints were the success rate, the change in the inflammatory (IN) lesion count, and the change in the non-inflammatory (NIN) lesion count.
The rating scale used was the investigator global assessment (IGA), which organizes acne into five categories: 0 = clear skin; 1 = almost clear skin; 2 = mild acne severity; 3 = moderate acne severity; and 4 = severe acne. In the new trial, the success rate was defined as the percentage of subjects with an IGA of clear/almost clear skin, and patients with moderate acne had to experience at least a two-grade improvement (i.e., advancing from an original IGA score of a 3 or 4 at baseline to a final IGA score of 0 or 1 at week 12).
The co-primary efficacy endpoints were met in both the overall population (moderate and severe acne) and in the severe-disease population only. In the overall population, 0.3% A/BPO demonstrated a superior success rate compared with vehicle (33.7% vs. 11.0%, respectively). In addition, the investigators observed superior changes in IN lesion counts with 0.3% A/BPO compared with vehicle (–27.0 vs. –14.4, respectively) and in NIN lesion counts (–40.1 vs. –18.4), as well as in the percent changes in IN lesion counts (–68.7% vs. –39.2%) and in NIN lesion counts (–68.3% vs. –37.3%, respectively) (all P < 0.001).
In the severe-disease subpopulation, 0.3% A/BPO was superior to vehicle in the success rate (31.9% vs. 11.8%, respectively; P = 0.029). In addition, superior changes in IN lesion (–35.1 vs. –15.4) and in NIN lesion counts (–45.6 vs. –17.2), as well as in percent changes in IN lesion (–74.4% vs. –33.0%) and NIN lesion counts (–72.0% vs. –30.7%, respectively) (all P < 0.001).
In the 0.3% A/BPO group, treatment-related adverse events (AEs) were mild to moderate in severity (15 AEs were reported in 12 subjects [5.5%]). One subject (0.5%) discontinued treatment because of an AE (atopic dermatitis flare). No treatment-related serious AEs were reported.
Acne is the most common skin condition in the U.S., affecting 40 to 50 million people. Propionibacterium acnes, a bacterium linked to acne, is becoming increasingly resistant to topical and oral antibiotics, which may potentially cause a decrease in treatment efficacy against the disease.
Source: Galderma Laboratories; March 20, 2015.