Epiduo Forte Gel shows efficacy in treating moderate-to-severe acne

Epiduo Forte Gel displayed significantly greater efficacy and had a good safety profile when compared with vehicle in treating patients with moderate-to-severe acne, according to published study results.

“There is an important need for antibiotic-free, topical treatments in managing moderate-to-severe inflammatory acne,” researcher Linda Stein Gold, MD, of the department of dermatology, Henry Ford Medical Center, Detroit, told Healio.com/Dermatology. “The data here have shown in the severe population, Epiduo Forte Gel [adapalene 0.3%/benzoyl peroxide 2.5%; Galderma] met the requirements for success, with a three-grade improvement to ‘almost clear’ and ‘clear,’ and showed a reduction in inflammatory and noninflammatory lesion counts.”

Stein Gold and colleagues conducted a multicenter, double-blind, parallel-group study of 503 patients with moderate-to-severe inflammatory facial acne, with patients stratified by acne severity: 50% with moderate acne and 50% with severe acne. The study included 217 patients randomly assigned to adapalene 0.3%/benzoyl peroxide 2.5% gel (0.3% A/BPO), 217 patients assigned to a benchmark treatment of adapalene 0.1%/benzoyl peroxide 2.5% gel (0.1% A/BPO) and 69 patients assigned to vehicle once daily for 12 weeks.

Success rate at week 12 and change in inflammatory and noninflammatory lesion counts from baseline to week 12 were co-primary endpoints. Safety endpoints also were measured. Success rate was defined as the percentage of patients with “clear” or “almost clear” and at least a 2-grade improvement on the Investigator’s Global Assessment.

The 0.3% A/BPO treatment was superior to vehicle for patients with a treatment difference of 22.7% (33.7% vs. 11%; 95% CI, 12.8-32.6).  The treatment was also superior for reduction of inflammatory lesion count from baseline (27 vs. 14.4) and noninflammatory lesion count (40.2 vs. 18.5). The percentage reduction for inflammatory lesions (68.7% vs. 39.2%) and noninflammatory lesions (68.3% vs. 37.4%) was also higher for the 0.3% A/BPO treatment, compared with vehicle.

The benchmark 0.1% A/BPO treatment did not achieve statistical significance for success rate for the patients with severe inflammatory acne when compared with vehicle treatment. However, there was significantly greater efficacy (P = .029) in the 0.3% A/BPO treatment compared with vehicle. In the 0.3% A/BPO treatment cohort, 90.7% of patients reported moderate-to-complete improvement of acne in week 12 compared with 40% of the vehicle cohort (P < .001).

There 0.3% A/BPO was found to be safe and well-tolerated, with the most common treatment-related adverse events reported were skin irritation in six patients and skin burning sensation in two patients.

“In this difficult-to-treat patient population, positive results of the study further advance our options in providing efficacious and safe topical treatment options,” Stein Gold said. – by Bruce Thiel

Disclosure: Stein Gold reports being an investigator, consultant and member of the speaker’s bureau for Galderma, and also a consultant and/or investigator for Allergan, Valeant and Ranbaxy. Please see the study for a full list of the other researchers’ relevant financial disclosures.