Combination gel Ziana improves acne lesions.
CHICAGO -- An aqueous gel formula that combines 0.025% tretinoin and 1.2% clindamycin phosphate significantly reduces both inflammatory and noninflammatory acne lesions, Dr. James Leyden said in a poster presented at the annual meeting of the Society for Pediatric Dermatology.
The combination gel, marketed as Ziana, has been approved by the Food and Drug Administration for once-daily topical treatment of acne vulgaris in children aged 12 years and older.
In a phase III study, 1,710 patients aged 12-18 years were randomized into four groups to receive the combination gel, a tretinoin-only gel, a clindamycin phosphate-only gel, or a placebo gel. The baseline acne conditions ranged from mild to severe; patients were required to have 20-100 noninflammatory lesions, 20-50 inflammatory lesions, and two nodules to enroll in the study.
Overall, the patients in the combination gel group showed significantly greater reductions in the number of inflammatory lesions, noninflammatory lesions, and total lesion counts after 12 weeks of daily treatment, compared with the other groups, wrote Dr. Leyden of Broomall, Pa. He has received financial support from several drug manufacturers, including Medicis Pharmaceutical Corp., which manufactures Ziana and sponsored the study.
The average reductions for inflammatory and noninflammatory lesions, respectively, were 46% and 35% for the combination group; 35% and 26% for the tretinoin group; 36% and 23% for the clindamycin phosphate group; and 16% and 9% for the placebo group.
The average reduction in total lesion count was 39% for the combination group, 30% for the tretinoin group, 29% for the clindamycin phosphate group, and 12% for the placebo group.
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|Title Annotation:||Clinical Rounds|
|Date:||Oct 1, 2007|
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