Acne Vulgaris Clinical Trial
Official title:
Comparison of Efficacy and Safety of Tricilest (Norgestimate-ethinyl Estradiol) and Diane-35 (Cyproterone Acetate-ethinyl Estradiol) in the Treatment of Acne Vulgaris
The purpose of this study was to evaluate the effectiveness and safety of norgestimate-ethinyl estradiol as comparted with cyproterone acetate-ethinyl estradiol among female patients with moderate acne vulgaris.
This study was to evaluate the efficacy and safety of TriCilest as comparted with Diane-35
among female patients with moderate acne vulgaris. The study design was double-blind,
randomized, parallel and active controlled. The sponsor planned to recruit approximately 50
patients to complete 40 evaluable patients. At the end of the study, a total of 48 patients
were randomized.
TriCilest (noregestimate-ethinyl estradiol), 0.18mg-0.035mg or 0.215mg-0.035mg or
0.25mg-0.035mg, Oral admistration, The duration was three consecutive menstrual cycles.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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