CD 5024 meets endpoints in Phase III trials for Rosacea - Galderma

Galderma has announced the results of two pivotal Phase III trials of CD 5024 (ivermectin 1%), an investigational drug being evaluated for the treatment of papulopustular (inflammatory) Rosacea. The results of the studies, in which 910 subjects applied ivermectin 1% cream once daily for 12 weeks, demonstrate that ivermectin is safe and effective.

Both pivotal studies met their co-primary efficacy endpoints. The effect was significant in all primary and sensitivity analyses at Week 12. 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% versus 27 subjects (11.6%) with vehicle. 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. In both studies, ivermectin 1% showed comparable tolerability and safety to the control group vehicle. The data were presented at the 72nd annual meeting of the American Academy of Dermatology (AAD).