flammatory lesion count at week 12 of −15.1 versus −11.2 in the placebo group (P less than 0.01). In study SC1402, the mean absolute change was −16.2 for sarecycline versus −13.4 for placebo (P less than 0.01) at week 12.Among patients who had ≥10 baseline noninflammatory lesions in study SC1401, the mean percentage change from baseline in noninflammatory lesion count was significantly greater for sarecycline than placebo starting at week 6 and continuing through week 12 (−34.5% vs −26.0%; P less than 0.05; Figure 6). In study SC1402, the mean percentage change from baseline in noninflammatory lesion count for patients with ≥10 baseline noninflammatory lesions was significantly greater for sarecycline than for placebo starting at week 9 and continuing through week 12 (−35.6% vs −28.2%; P less than 0.01). Figure 7 shows photographs depicting response to sarecycline treatment at week 12 in representative patients in studies SC1401 and SC1402.Among patients who had baseline IGA scores of ≥ 2 for back or chest acne, the proportions achieving IGA success at these locations (≥2-point improvement in IGA score) at week 12 were significantly higher in the sarecycline than the placebo group in both studies (Figure 8). For back acne, this comparison was significant beginning at week 3 in study SC1401 and at week 9 in study SC1402. For chest acne, significance was noted at week 6 and week 12 in study SC1401, and at week 12 in study SC1402.In study SC1401, significant mean differences for sarecycline over placebo (95% CI) were achieved in Skindex-16 scores for symptoms (−4.7 [−7.0, −2.4]), and emotion (−4.7 [−8.1, −1.4]) scales, and total score (−3.5 [−6.0, −1.1]). The mean difference for functioning (95% CI) was −1.5 (−4.3, 1.3). In study SC1402, the mean differences for sarecycline over placebo (95% CI) were significant for symptoms (−5.1 [−7.2, −2.9]), emotion (−7.7 [−11.0, −4.4]), functioning (−4.8 [−7.3, −2.2]), and total score (−5.9 [−8.1, −3.6]).
