Clinical trial NCT01466673: An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Official title: Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Ethinyl estradiol
Norgestimate
Desogestrel
Tricilest
Oilezz
Lead sponsor: Janssen-Cilag Ltd.,Thailand
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria: - Needs contraception in the family planning - Mild to moderate acne vulgaris - Agrees to take only the supplied study drug as treatment for acne during the 6-month treatment phase of the study - Signs and dates an informed consent to participate in the study - female participants aged 18 to 45 years Exclusion Criteria: - Pregnant or nursing - Known hypersensitivity to any of the ingredients and currently having significant adverse experiences from ethinyl estradiol, norgestimate or desogestrel - Any coexisting medical condition or were taking any concomitant medication that is likely to interfere with safe administration of ethinyl estradiol/norgestimate and ethinyl estradiol/desogestrel, in the Investigator's opinion - Taking system retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively - Taking investigational medication or oral contraceptives within 30 days prior to Screening

Primary outcomes:
measure: Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
timeFrame: Baseline and Month 1
measure: Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
timeFrame: Month 1, 3 and 6
measure: Number of Participants Non-Compliant With Therapy
timeFrame: Month 1, 3 and 6
measure: Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
timeFrame: Baseline and Month 1, 3 and 6
measure: Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
timeFrame: Month 6
measure: Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
timeFrame: Month 6
measure: Change From Baseline in Blood Pressure (BP) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Body Weight at Month 6
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
city: Bangkok
country: Thailand
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Mahidol University
city: Chiang Mai
country: Thailand
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Janssen-Cilag Ltd.,Thailand
name: Janssen-Cilag Ltd., Thailand Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Jaisamrarn U, Chaovisitsaree S, Angsuwathana S, Nerapusee O. A comparison of multiphasic oral contraceptives containing norgestimate or desogestrel in acne treatment: a randomized trial. Contraception. 2014 Nov;90(5):535-41. doi: 10.1016/j.contraception.2014.06.002. Epub 2014 Jun 12.