Medknow Publications on behalf of The Indian Association of Dermatologists, Venereologists and Leprologists (IADVL)
Abstract
BACKGROUND: Tazarotene is a new third generation topical acetylenic
retinoid. The present study was conducted to evaluate the efficacy and
safety of tazarotene gel (0.1%) in Indian patients of acne vulgaris.
METHODS: The present study was a prospective, open, multicentric, phase
III trial. The duration of study was 14 weeks, including a 12-week
active treatment period, preceded by a 2-week washout phase. Patients
applied 0.1% tazarotene gel as a thin film over the affected area once
daily in the evening. The efficacy was evaluated by analyzing changes
in the number of facial acne lesions and patient's and physicians'
global assessment. The efficacy parameters were assessed at baseline,
visits 2, 4, 8, and 12 weeks. Tolerability and safety was assessed by
physical examination, laboratory parameters and evaluation of adverse
events. RESULTS: A total of 126 patients in 6 centers completed the
study. At the end of the 8th and 12th weeks, the mean number of
inflammatory lesions reduced by 70.6% and 86.1%, non-inflammatory
lesions by 81.5% and 92%, and total lesion count 75.6% and 88.8%
respectively from baseline. Also, 90.7% and 93.6% of total study cases
showed complete to moderate clearance of acne lesions according to
physicians at the end of the 8th and 12th weeks. CONCLUSIONS: This
study confirms the efficacy and safety of tazarotene gel (0.1%) in
Indian patients of acne vulgaris