Comparison of Tazarotene and Minocycline Maintenance Therapies in Acne Vulgaris.pdf

STUDY Comparison of Tazarotene and Minocycline Maintenance Therapies in Acne Vulgaris A Multicenter, Double-blind, Randomized, Parallel-Group Study James Leyden, MD; Diane M. Thiboutot, MD; Alan R. Shalita, MD; Guy Webster, MD, PhD; Kenneth Washenik, MD, PhD; Bruce E. Strober, MD, PhD; Jerome Shupack, MD Objective: To evaluate the efficacy of 3 maintenance regimens (topical tazarotene, oral minocycline hydro- chloride, or both) in sustaining improvement in acne. Design: Multicenter, open-label treatment phase fol- lowed by double-blind, randomized, parallel-group main- tenance phase. Setting: Ambulatory patients in research or referral centers. Patients: Volunteer sample of 189 patients with mod- erately severe to severe acne vulgaris (110 entered main- tenance phase, 90 completed, and 2 discontinued be- cause of adverse events). Interventions: All patients were treated with 0.1% taz- arotene 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 Measures: Overall disease severity, global improvement, and lesion counts. Results: All regimens were effective in sustaining im- provements in acne. After 12 weeks of maintenance therapy, the mean reductions from baseline in nonin- flammatory and inflammatory lesion count, respec- tively, 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 im- provement from baseline, and more than 50% had main- tained a 75% or greater global improvement. Conclusions: A high percentage of patients with mod- erately severe to severe acne can maintain improvement in their condition with topic