ORLANDO – A three-component combined over-the-counter and prescription skin care regimen was safe, effective, well tolerated, and well liked by acne vulgaris patients aged 12 years and older in an open-label multicenter study.
Of 81 participants with a mean age of 19 years, mild or moderate facial acne vulgaris, and mean acne vulgaris duration of 4.4 years, 89.2% agreed or strongly agreed that they liked the regimen, 87.9% reported overall satisfaction, and 87.9% said they would recommend the regimen to others.
Dr. Michael H. Gold
Nearly all participants (95.9%) said the regimen was easy to use, 73% reported improved skin texture, and 70.3% said the regimen met their needs, Dr. Michael H. Gold of Nashville, Tenn., reported in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.
Treatment involved once-daily application of a prescription topical gel containing adapalene 1% and benzoyl peroxide 2.5%, as well as the use of two over-the-counter products designed for acne-prone skin: a foaming cleanser used twice daily and a moisturizer with broad spectrum SPF 30 sunscreen used once daily. Treatment continued for 8 weeks.
In addition to the subjective patient satisfaction questionnaire, subjects were assessed based on total inflammatory and noninflammatory lesion counts; photographic evaluation of skin shininess, texture, and presence of Propionibacterium acnes; cutaneous tolerability scores for stinging, burning, erythema, scaling, and dryness; and adverse events.
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The therapeutic effect was evident in most patients at 2 weeks, with a reduction in the number of lesions. After 8 weeks, total inflammatory and noninflammatory lesion counts were significantly reduced, compared with baseline. Skin shininess and P. acnes also were significantly reduced by 8 weeks, Dr. Gold noted.
Most patients had no cutaneous irritation; the proportion of patients experiencing irritation was smaller than in prior phase II and III studies that evaluated benzoyl peroxide once-daily gel with or without moisturizer. Of 553 patients from those prior studies, 4% and 1% reported moderate and severe erythema, respectively, compared with 1% and 0% of the patients in the current study. In addition 3% and 1% of patients in earlier phase II and III studies, respectively, reported moderate or severe stinging/burning, compared with none of the patients in the current study.
A total of 18 adverse events were reported by 13 patients in the current study, and 17 events were considered to be related to the skin care regimen. None of the affected patients discontinued the regimen, and none of the patients reported serious adverse events.
Of note, 70% of patients agreed or strongly agreed that a sunscreen made for acne-prone skin was important to them, Dr. Gold said.
He and his colleagues concluded that a complete three-component, acne-specific regimen designed to clean, moisturize, medicate, and photoprotect is important for optimizing patient outcomes, and that the regimen used in this study was associated with good outcomes and high levels of patient satisfaction.
This study was funded by Galderma Laboratories.