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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of tazarotene and minocycline maintenance therapies in acne vulgaris: a multicenter, double-blind, randomized, parallel-group study.
- James Leyden, Diane M Thiboutot, Alan R Shalita, Guy Webster, Kenneth Washenik, Bruce E Strober, and Jerome Shupack.
- Skin Study Center, Broomall, PA, USA. jjleyden@mindspring.com
- Arch Dermatol. 2006 May 1; 142 (5): 605-12.
ObjectiveTo evaluate the efficacy of 3 maintenance regimens (topical tazarotene, oral minocycline hydrochloride, or both) in sustaining improvement in acne.DesignMulticenter, open-label treatment phase followed by double-blind, randomized, parallel-group maintenance phase.SettingAmbulatory patients in research or referral centers.PatientsVolunteer sample of 189 patients with moderately severe to severe acne vulgaris (110 entered maintenance phase, 90 completed, and 2 discontinued because of adverse events).InterventionsAll patients were treated with 0.1% tazarotene gel (each evening) and a 100-mg capsule (twice daily) of minocycline hydrochloride for up to 12 weeks. Patients with 75% or greater global improvement at week 12 were randomly assigned to 12 weeks of maintenance therapy with tazarotene gel plus placebo capsules, vehicle gel plus minocycline capsules, or tazarotene gel plus minocycline capsules.Main Outcome MeasuresOverall disease severity, global improvement, and lesion counts.ResultsAll regimens were effective in sustaining improvements in acne. After 12 weeks of maintenance therapy, the mean reductions from baseline in noninflammatory and inflammatory lesion count, respectively, were 60% and 54% with tazarotene, 52% and 66% with minocycline, and 64% and 66% with tazarotene plus minocycline. At week 24, more than 80% of patients in each group had maintained a 50% or greater global improvement from baseline, and more than 50% had maintained a 75% or greater global improvement.ConclusionsA high percentage of patients with moderately severe to severe acne can maintain improvement in their condition with topical retinoid monotherapy. Maintenance with combination tazarotene and minocycline therapy showed a trend for greater efficacy but no statistical significance vs tazarotene alone. Topical retinoid monotherapy should be considered for maintenance to help minimize antibiotic exposure.
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