Effects of subantimicrobial-dose XXXX in the treatment of moderate acne.

@entity1 @entity3403
OBJECTIVE: To determine if treatment with subantimicrobial-dose (SD) @entity3403 (20-mg tablets taken twice daily) improved clinical outcome, had any detectable effect on skin flora, led to overgrowth or colonization of skin by opportunistic pathogens, or resulted in an increase in antibiotic resistance by the surface skin microflora in @entity1 with moderate acne compared with placebo. DESIGN: Multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. SETTING: Two university-based clinics. SUBJECTS: Adults (N = 51) with moderate facial acne. INTERVENTIONS: @entity1 were randomized to receive SD @entity3403 ( @entity3403 ; CollaGenex Pharmaceuticals Inc, Newtown, Pa) or placebo twice daily for 6 months. MAIN EFFICACY OUTCOMES: Primary: changes from baseline in numbers of inflammatory, noninflammatory, and total lesions. Secondary: changes from baseline of individual counts of papules, pustules, and nodules and global assessments of clinical improvement by @entity1 and physician. RESULTS: Forty @entity1 completed 6 months of treatment. At 6 months, the SD @entity3403 group had a significantly greater percent reduction in the number of comedones (P<.01), inflammatory and noninflammatory lesions combined (P<.01), and total inflammatory lesions (P<.05) than did the placebo group. They also had significantly greater improvement according to the clinician's global assessment (P =.03). There were no significant differences in microbial counts between groups and no evidence of change in antibiotic susceptibility or colonization by potential pathogens. The treatment was well tolerated. CONCLUSIONS: Twice-daily SD @entity3403 treatment significantly reduced the number of inflammatory and noninflammatory lesions in @entity1 with moderate facial acne, was well tolerated, had no detectable antimicrobial effect on the skin flora, and did not result in any increase in the number or severity of resistant organisms.
