Lara C. Pullen, PhD

April 08, 2015

Topical gel combinations of adapalene and benzoyl peroxide appear to be safe and effective in the long-term management of patients with moderate to severe inflammatory acne, according to two new studies.

In a phase 3 study of patients with moderate and severe acne, the success rate was better with the investigational formulation of adapalene 0.3% and benzoyl peroxide 2.5% than with the inactive vehicle (33.7% vs 11.0%), said investigator Jonathan Weiss, MD, from Gwinnett Dermatology, PC, and the Gwinnett Clinical Research Center in Snellville, Georgia.

And the formulation of adapalene 0.1% and benzoyl peroxide 2.5%, which is approved for use by the US Food and Drug Administration, decreased the severity of acne in an observational study.

Results from both studies were presented during a poster session at the American Academy of Dermatology 73rd Annual Meeting in San Francisco.

In the large multicenter, prospective, noninterventional study of the 0.1% gel, mean acne severity, measured on Leeds revised scale, decreased from 5.6 at baseline to 3.3 at month 3 and 1.9 at month 9 (P < .001). In addition, at month 9, acne resolved in 26% of patients.

In this cohort, 84% of the patients were considered to be adherent after 9 months of treatment with the 0.1% gel, used with or without other acne treatments. The high rate of use might be an important aspect of treatment, the researchers report.

 
The most effective therapy is not only the one that demonstrates efficacy, it is the one that patients continue to use.
 

"Combining drugs with different mechanisms of action is the best way to treat acne because that targets as many pathogenic factors as possible," said Joshua Zeichner, MD, from Mount Sinai Hospital in New York City, who was not involved in either study.

Although most trials last 12 weeks, "acne lasts for much longer and requires chronic treatment. The most effective therapy is not only the one that demonstrates efficacy, it is the one that patients continue to use," Dr Zeichner told Medscape Medical News.

"The bottom line is that the 0.1% formulation works somewhat after 9 months for the moderate acne patient," said Carolyn Jacobs, MD, from Chicago Cosmetic Surgery and Dermatology, who was not involved in either study.

However, the investigators did not separate out the 21% of patients who also used other topicals or pills, or the 21% to 33% who experienced dryness or irritation while using the medication, she told Medscape Medical News.

"It's surprising that it didn't work better after 3 months," Dr Jacobs said. She pointed out that most went from moderate to low-moderate acne in 12 weeks, but not to mild acne, and that the investigators didn't measure clearance at 3 months.

The multicenter, randomized, double-blind, phase 3 clinical trial involved 503 patients with moderate or severe acne. Patients were randomly assigned to one of three groups.

For 12 weeks, 217 patients used the 0.3% formulation, 217 used the 0.1% formulation, and 69 used vehicle once daily.

The end points were success rate, defined as an improvement of at least 2 grades on the Investigator's Global Assessment scale, and the change in inflammatory and noninflammatory lesion count.

The success rate was better with the 0.3% gel than with vehicle, as was the mean reduction in inflammatory lesion count (27.0 vs 14.4) and noninflammatory lesion count (40.1 vs 18.4).

Table. Success Rate With the 0.3% Gel

Week 0.3% Gel, % Vehicle, % P Value
1 1.0 0.0 ns
2 3.0 0.0 ns
4 4.3 1.5 ns
8 13.0 3.1 .017
12 33.5 11.5 .001

 

The success rate was also better with the 0.3% formulation than with vehicle when only patients with severe acne were included in the analysis (31.9% vs 11.8%), Dr Weiss told Medscape Medical News.

The safety profiles of the 0.3% and 0.1% gels were comparable.

The 0.3% gel was better than the 0.1% gel, although not significantly. However, the study was not powered to test the superiority of one formulation over the other.

"This is another formulation of a drug that we already know works," said Charles Johnston, MD, from Facets Private Healthcare Group in Oak Park, Illinois, who was not involved in either study.

It would be interesting to see how it compares to the already approved 0.1% formulation, he told Medscape Medical News.

Both studies were funded by Galderma. Dr Weiss and Dr Johnston have disclosed no relevant financial relationships. Dr Zeichner has served as an advisory board member and consultant for Galderma. Dr Jacobs is a speaker for several dermatologic companies, including Allergen and Valeant, on acne treatments and a speaker for Galderma on rosacea medications.

American Academy of Dermatology (AAD) 73rd Annual Meeting: Abstracts 790 and 1773. Presented March 21, 2015.

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