Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and 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.
Drug: Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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 primary efficacy variable was the change form baseline to the latest available evaluation in total lesion count. The primary efficacy result of this study clearly manifested the potency of TriCilest.
- The secondary efficacy variable (change in lesion counts) showed consistent results to the primary efficacy endpoint.
|Study Start Date:||September 2004|
|Study Completion Date:||September 2005|
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.