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.
ABSTRACT
AIM OF STUDY: Tacrolimus, a topical immunomodulator, has been introduced as a new treatment for moderate to severe atopic dermatitis. The present study was conducted to evaluate the efficacy, safety and tolerability of Tacrolimus ointment in patients of atopic dermatitis in an Indian setting. METHODS: The present study was a prospective, open, multicentric, Phase III trial.The duration of study was 5 weeks, including a 3-week active treatment period, preceded by a 1-week washout phase and followed by a 1-week follow-up phase. Patients diagnosed to be suffering from moderate to severe atopic dermatitis as per the Rajka and Langeland criteria were treated with Tacrolimus ointment 0.03% twice daily. Efficacy was assessed by modified Eczema Area Sensitivity Index (mEASI) score, patient's and physician's global assessment. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events. RESULTS: There was a statistically significant decrease in the modified Eczema Area Sensitivity Index (mEASI) score (P< 0.05). Patient's and Physician's global evaluation of treatment was complete resolution to very good improvement in most of the patients. The laboratory values were within normal limits. The drug was well tolerated. CONCLUSIONS: This study confirms the efficacy and safety of Tacrolimus ointment 0.03% in Indian patients of moderate to severe atopic dermatitis.