| Methods |
Multicenter trial in U.S. Participants and investigators were blinded.
6‐week washout period for retinoid use, 1 month for systemic acne, 2 weeks for topical acne and 3 months for oral or injectable contraception; 6 treatment cycles |
| Participants |
371 healthy women at least 14 years of age with regular menstrual cycles and moderate facial acne. Other inclusion criteria were normal or low grade abnormal Papanicolaou smear within the past 6 months, negative pregnancy test and agreement to use a non‐hormonal contraceptive if at risk of pregnancy. Excluded women with contraindications to OCs, smoking in women over 35 years old or use of sex hormones within 6 months of enrollment. |
| Interventions |
Group 1: LNG 100 µg plus EE 20 µg
Group 2: Placebo |
| Outcomes |
Acne lesion counts.
Clinician global assessment using 4‐point scale ("clear," "almost clear/mild," "moderate" or "severe") adapted from an American Academy of Dermatology consensus statement.
Participant self‐assessment. |
| Notes |
Randomization in blocks of 4 using a computer‐generated schedule. Medication code was provided in individual sealed envelopes labeled according to the randomization schedule. Did not specify if envelopes were opaque or not. 125 women discontinued early or were lost to follow up. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Medication code was provided in individual sealed envelopes labeled according to the randomization schedule. Did not specify if envelopes were opaque or not. |
