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A newly approved acne medication that combines adapalene and benzoyl peroxide has shown safety and efficacy with daily use for up to one year and does not contribute to antibiotic resistance, a researcher says.
"Epiduo is the first combination product that does not contain an antibiotic," says David M. Pariser, M.D., the study's lead author and professor, department of dermatology, Eastern Virginia Medical School, Norfolk, Va.
Although Epiduo's active ingredients aren't new, "The combination is. It gives us another color to paint with in our palette of drugs that we can use in the treatment of acne," Dr. Pariser tells Dermatology Times.
For the study, investigators enrolled 452 subjects (62 percent with skin phototype 1, 2 or 3) whose mean age was approximately 18 years. At baseline, all patients had 30 to 100 noninflammatory facial lesions, 20 to 50 inflammatory facial lesions and no active nodules or cysts.
A total of 125 patients discontinued treatment before the study's 12-month endpoint, 70 by their own requests. Only nine subjects discontinued treatment due to at least one adverse event.
Overall, investigators evaluated 397 patients for three months or more, 366 for six months or more and 334 for nine months or more.
Mean duration of exposure was 295 days, and no patients discontinued treatment due to lack of efficacy.
In fact, Dr. Pariser says, "During the entire year, there was no loss of efficacy over time. Nor were there any unexpected side effects."
For the intent-to-treat population, treatment achieved reductions in total, inflammatory and noninflammatory lesions of 70.8 percent, 76 percent and 70 percent, respectively.
For all types of lesions, treatment began to have effects as early as week one, Dr. Pariser says.
Lesion counts continued to decrease to levels between 65 percent and 70 percent through the study's first four months, and treatment maintained these reductions for the duration of the study.
In total, 330 subjects (80.3 percent) reported a moderate, marked or complete improvement, while 45 subjects (10.9 percent) reported minimal improvement, and 36 subjects (8.8 percent) reported no change or worsening of acne at the study's end.
On the whole, the study's results were as expected, and they were consistent with previous research, Dr. Pariser says.
Disclosure: Galderma paid Dr. Pariser an honorarium for his work as an investigator.
For more information: http://www.pariserderm.com/