Table 2.
Primary outcome: Acne-QoL symptom subscale score
| Spironolactone (n=201) | Placebo (n=209) | Mean difference | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Time | Participants | Mean score | Participants | Mean score | Unadjusted* | Adjusted* | Adjusted† (100 imputations) | ||
| Week 6 | 176 | 17.0 (6) | 179 | 15.6 (6) | NA | NA | NA | ||
| Week 12 | 176 | 19.2 (6) | 166 | 17.8 (6) | 1.48 (0.30 to 2.67) | 1.27 (0.07 to 2.46) | 1.26 (0.04 to 2.48) | ||
| Week 24 | 163 | 21.2 (6) | 136 | 17.4 (6) | 3.77 (2.50 to 5.03) | 3.45 (2.16 to 4.75) | NA | ||
| Week 52 | 95 | 21.7 (6) | 81 | 20.0 (6) | NA | NA | NA | ||
Data are number, mean (standard deviation), or mean difference (95% CI). CI=confidence interval; IGA=investigator’s global assessment; NA=not applicable; QoL=quality of life.
*
Week 6 data are not presented as participants were not yet on full dose of spironolactone. Week 52 data not presented as participants were unmasked at 24 weeks and both groups could seek any treatments after that point, including spironolactone.
†
Adjusted for stratification factors (site and baseline severity (IGA <3 versus 3 or more)), baseline Acne-QoL symptom subscale score, topical treatment use (yes/no to using any topical treatment), hormonal treatment, age, and polycystic ovary syndrome status.