| Methods |
Multicenter, placebo‐controlled trial in U.S. Investigators, study staff, data analyst and participants were blinded. Washout periods were 3 months for OCs and levonorgestrel implant, 6 months for depomedroxyprogesterone acetate and systemic retinoids, 1 month for systemic antibiotics and 2 weeks for topical medications.
6 treatment cycles. |
| Participants |
257 healthy women aged 15 to 49 years with moderate acne vulgaris. Women at risk of pregnancy had to be willing to use a non‐hormonal contraceptive method. Excluded women with hirsutism or contraindications to COCs. |
| Interventions |
Group 1: Triphasic norgestimate (NGM) 180‐215‐250 µg plus EE 35 µg
Group 2: Placebo |
| Outcomes |
Acne lesion counts.
Clinician global assessment of acne.
Participant self‐assessment of acne.
Early discontinuation due to side effects and due to worsening of acne. |
| Notes |
Computer‐generated randomization schedule. No information on allocation concealment. 85 women were excluded, discontinued early or were lost to follow up. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
