| Methods |
Double‐blind randomized trial in 56 centers in Russia (17), Germany (13), Ukraine (12), Czech Republic (9), and Netherlands (5); 6 treatment cycles. No mention of who was blinded. Randomization done via a computer‐generated randomization list. A priori sample size calculations provided. Analysis conducted by intent to treat and per protocol methods. |
| Participants |
1154 healthy women, age 15 to 40 years. Inclusion criteria: 6 to 100 comedones, 10 to 50 papules or pustules, not more than 5 nodules on face; washout for OCs (3 cycles), systemic retinoids or DMPA (6 months), systemic anti‐acne agents (4 weeks), topical retinoids (4 weeks), and other topical treatments (2 weeks); normal gynecologic exam and cervical smear within 6 months; negative pregnancy test; 3 spontaneous withdrawal bleeds after delivery, abortion, or lactation; no comedogenic cosmetics or sunscreens, sex hormone preparation, or anti‐acne therapy.
Exclusion criteria: > 30 years and smoking; pregnant or lactating; acne comedonica or nodulocystic/conglobate acne; acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts; previous acne treatment failure with sex hormones for >= 3 months; or need for other medication with acne‐inducing effects. |
| Interventions |
Group 1: DRSP 3 mg plus EE 30 µg
Group 2: NGM 180‐215‐250 µg plus EE 35 µg |
| Outcomes |
Primary: from baseline to cycle 6 ‐ percent change in inflammatory lesion count (papules, pustules, nodules) and percent change in total lesion count (papules, pustules, nodules, and open and closed comedones); proportion of subjects with facial acne improvement by investigators' assessment.
Secondary: subject's and investigator's assessment of treatment effect; changes in sebum production and hormone levels; and bleeding record.
Discontinuation. |
| Notes |
No information on allocation concealment. Study conducted from May 2000 to September 2001.
Exclusions after randomization, 2 from DRSP group and 4 from NGM group. Early discontinuation: 6% DRSP group and 7% NGM group. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
