Antibiotic-free treatment effective, safe for moderate-to-severe acne

An antibiotic-free investigational acne treatment adapalene 0.3%/benzoyl peroxide 2.5% topical gel (0.3%A/BPO, Galderma) yielded positive results in a phase 3 study. Researchers presented their findings, comparing 0.3%A/BPO to vehicle for moderate-to-severe acne, at this year’s American Academy of Dermatology annual meeting in San Francisco, Calif.

Ronald G. Wheeland, M.D. says, “The increased strength of adapalene (a retinoid) is a valuable ingredient to explore in view of the growing incidence of drug resistance and the fact that it apparently worked in moderate to severe acne patients is a very good sign.”

Dr. Wheeland is a private practitioner in Tucson, Ariz. He is former president of the American Academy of Dermatology, the American Society for Dermatologic Surgery and the American Society for Laser Medicine and Surgery, and a long-standing member of the Dermatology Times editorial Advisory board.

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Jonathan Weiss, M.D.,The topical, which is being evaluated by the FDA, meets an unmet need among acne patients, according to the trial’s lead investigator Jonathan Weiss, M.D., Gwinnett Clinical Research Center, Snellville, Ga.: “While there are effective and antibiotic-free treatment options available for various stages of acne (mild, moderate, severe), patients suffering from moderate-to-severe acne are more prone to relapse, indicating there is an unmet need in treating this patient population.”     “[0.3%A/BPO] is a fixed-dose combination treatment developed with a higher concentration of adapalene than that contained in Epiduo (adapalene/benzoyl peroxide) Gel, 0.1%/2.5%,” Dr. Weiss says. 

In the multicenter, randomized, double-blind, Galderma-supported study, researchers looked at 503 subjects, ages 12 years and older, who were treated with 0.3% A/BPO, 0.1% A/BPO or vehicle gel once daily for 12 weeks. The overall study population had moderate-to-severe acne, but a severe-acne-only subgroup was studied, as well. Study endpoints were success rate, defined as clear or almost clear after 12 weeks; change in inflammatory lesion count; and change in non-inflammatory lesion count.

NEXT: Findings

Among the findings:

·      In the overall population, 33.7% of subjects treated with 0.3% A/BPO achieved the success rate, versus 11.0% on vehicle.

·      In the severe-acne-only group, nearly 32% achieved the success rate with the investigational drug, compared to 11.8% with vehicle.  

·      The percent reduction in inflammatory and non-inflammatory lesions after 12 weeks of treatment were 69% and 67%, respectively, for 0.3%A/BPO, according to Dr. Weiss.

·      The investigational drug was well tolerated, with a similar local tolerability profile to 0.1% A/BPO. Treatment-related adverse events, of mild to moderate severity, occurred in 5.5% of those treated with investigational drug. There were no adverse events among the controls. None of the adverse events were serious.

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The intention of the study was not to compare 0.3% A/BPO to 0.1% A/BPO, according to Dr. Weiss. “It should be noted that while 0.1% A/BPO was included for benchmarking purposes, this study was not designed or powered for formal hypothesis testing of superiority between 0.3% vs 0.1%, and, therefore, efficacy data for the 0.1% arm was not in the poster,” he says. “The difference between this study and previous studies of 0.1% A/BPO is that this study was stratified and powered to evaluate the efficacy of tests products versus vehicle in both moderate and severe populations.”

NEXT: Unique to phase 3 trial

Unique to this phase 3 trial, according to Dr. Weiss: The success rate was defined as percentage of subjects with an investigator global assessment (IGA) of clear or almost clear skin.

“… patients with moderate acne had to experience at least a two-grade improvement--advancing from an original IGA score of a three or four at baseline to a final IGA score of zero or one at week 12.  Additionally, patients with severe acne had to achieve an IGA of clear or almost clear skin and a three-grade improvement in order to be counted as a study success,” Dr. Weiss says.

Dermatologist Whitney Bowe, M.D.Dermatologist Whitney Bowe, M.D., with offices in New York City and Briarcliff Manor, N.Y., says the phase 3 study is solid and demonstrates that the new formulation will be a welcomed addition to the dermatologist’s acne armamentarium.  

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 “Despite the increased concentration of adapalene, the product was clearly well-tolerated and side effects [were] minimal.  With the increase in antibiotic resistance, I'm pleased to see such a powerful antibiotic-free alternative coming our way,” Dr. Bowe says. “Based on the tolerability profile and minimal side effects, I will likely use this as a first-line agent in my practice, knowing that it will work even for my most severe cases.”

Dr. Wheeland notes, “One concern I have is whether this increased strength will result in more irritation in some patients which could limit its usefulness, especially in non-teenagers.  Also will this increased [strength] cause concern about its use in women of reproductive potential due to the known teratogenic effects seen with oral dosing. All things considered, I think there is a great deal of potential for use of this product.”

NEXT: References

Disclosures: Dr. Wheeland has no relevant disclosures. Dr. Bowe is a consultant and is on the advisory board for Galderma.