Phase 4
Completed N=201
An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Source: ClinicalTrials.gov NCT01466673 ↗Enrolled (actual)
201
Serious AEs
1.0%
Results posted
Jun 2013
Primary outcomePrimary: Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 — 10.97; 11.43; 4.32; 4.46 Lesions
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 |
10.97; 11.43; 4.32; 4.46; 0.90; 1.12 | — |
| PRIMARY Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3 |
5.71; 5.60; 2.83; 1.89; 0.63; 0.70 | — |
| PRIMARY Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6 |
9.02; 8.21; 3.52; 2.77; 0.77; 0.96 | — |
| SECONDARY Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 |
5; 2; 6; 4; 4; 3 | — |
| SECONDARY Number of Participants Non-Compliant With Therapy |
7; 5; 13; 10; 10; 6 | — |
| SECONDARY Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 |
3.00; 3.96; 10.00; 12.87; 43.00; 44.55 | — |
| SECONDARY Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 |
5.05; 1.03; 4.04; 1.03; 4.04; 23.71 | — |
| SECONDARY Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 |
47; 35; 45; 58; 3; 3 | — |
| SECONDARY Change From Baseline in Blood Pressure (BP) at Month 6 |
110.6; 110.2; 70.23; 69.47; 0.33; -0.24 | — |
| SECONDARY Change From Baseline in Body Weight at Month 6 |
55.62; 54.24; -0.08; -0.20 | — |
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
Data sourced from ClinicalTrials.gov (NCT01466673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.