NCT01466673

An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment

Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Janssen-Cilag Ltd.,Thailand · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment of female participants with mild to moderate acne vulgaris (pimples).

Detailed description

This is a single-blind (physician does not know the name of the assigned drug) and randomized (study drug assigned by chance) study to compare the effectiveness and safety of EE/NGM and EE/DSG in female participants using oral contraceptive and have mild to moderate acne vulgaris. Tablets of EE/NGM and EE/DSG will be administered orally once daily for 6 months and will be instructed to visit for evaluation at Month 1, 3 and 6 post-administration. The efficacy will be evaluated efficacy primarily through total acne lesions count, which will be recorded at these evaluation visits. Unused study medications will be collected and drug accountability will be documented. Participants' safety will be monitored throughout the study.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Ethinyl estradiol/Norgestimate (EE/NGM)	Ethinyl estradiol/Norgestimate encapsulated oral tablet will be administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
DRUG	Ethinyl estradiol/Desogestrel (EE/DSG)	Ethinyl estradiol/Desogestrel oral formulation will be administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2011-11-08
• Last updated: 2013-06-19
• Results posted: 2013-06-19

Locations

3 sites across 1 country: Thailand