LAS VEGAS — Treating acne with 4.5% or 8.5% benzoyl peroxide in a 10% urea vehicle once daily for 4 weeks was effective and well-tolerated, results from a large study demonstrated.
The finding underscores urea's role as an effective moisturizing agent, Michael H. Gold, M.D., reported during a poster session at the Fall Clinical Dermatology Conference.
In an open-label study that Dr. Gold led at 133 clinical sites, 1,089 men and women were prescribed 4.5% or 8.5% benzoyl peroxide in a 10% urea vehicle cleanser (Zoderm) for use in the morning plus an equivalent strength of either Zoderm gel or cream formulation for use in the evening.
Applications were made over a 4-week period. The investigators allowed patients to use additional acne medicines during the study, except for those that contained benzoyl peroxide.
Of the 1,089 patients, 963 completed the second visit of the study, Dr. Gold, a dermatologist with Tennessee Clinical Research Center, Nashville, noted in the text of the poster.
The investigators assessed inflammatory and noninflammatory lesion counts at baseline and at week 4. They rated dryness and erythema on a 0–8 scale in which 8 was defined as severe or deep.
Of the 963 patients, 551 used 4.5% or 8.5% benzoyl peroxide in urea vehicle as monotherapy, 17 used 4.5% or 8.5% benzoyl peroxide in urea vehicle with oral doxycycline, and 21 used 4.5% or 8.5% benzoyl peroxide in urea vehicle with oral minocycline.
Dr. Gold reported that the 551 patients who used 4.5% or 8.5% benzoyl peroxide in urea vehicle as monotherapy achieved a 44% mean reduction in total lesion count at week 4 vs. baseline.
The 17 patients who used this regimen plus oral doxycycline achieved a 52% mean reduction in their total lesion count at week 4 vs. baseline, whereas those patients who used concomitant oral minocycline achieved a 34% mean reduction in total lesion count at week 4 vs. baseline.
According to the poster, patients experienced little or no increase in skin dryness and a decrease in erythema.
The study was funded by a grant from Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals Inc., makers of Zoderm.
The meeting was sponsored by the Center for Bio-Medical Communication Inc.
A female patient is shown here at baseline, before using a urea vehicle cleanser.
Clearance of acne is apparent in the same patient at 4 weeks' follow-up. Photos courtesy Dr. Michael H. Gold