Galderma announced results from two Phase 3 trials of ivermectin 1%, an investigational drug being evaluated for the treatment of papulopusular rosacea.
Both studies were randomized, double-blind, 12-week vehicle controlled parallel–group studies assessing the efficacy and safety of ivermectin 1% cream in subjects with papulopustular rosacea.
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The co-primary efficacy endpoints were met for both studies. The effect was significant (P<0.001) in all primary and sensitivity analyses at Week 12 (ITT-LOCF). Onset of treatment effect was observed at week 4 in each study. The first co-primary endpoint was success rate (percent of subjects rated clear or almost clear on the IGA rating scale) at Week 12. In Study 1, 173 subjects (38.4%) were assessed as success with ivermectin 1% vs. 27 subjects (11.6%) with vehicle (P<0.001). Statistical significance was observed from Week 4 with success in 49 (10.9%) and 13 (5.6%) patients for ivermectin 1% and vehicle, respectively. The results were consistent between the studies.
The second co-primary endpoint was reduction in inflammatory lesions, and both studies also demonstrated that ivermectin 1% was significantly superior to vehicle in reducing lesion counts, with statistical significance apparent at week 2 and continuing for the duration of the study. Trial patients using ivermectin 1% also showed an average reduction of more than 20 lesions vs. a reduction of 12 and 13.4 lesions respectively in the control groups.
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