drugset / Trial / NCT01616654

Dose Range Study of CD5789 in Acne Vulgaris

NCT01616654 ↗

Phase 2 Completed 304 enrolled Galderma R&D
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.

Timeline

Start
2012-06-20
Primary completion
2013-07-24
Completion
2014-06-12

Outcome

Mixed primary results

registry analysis (superiority test); CD5789 50 mcg/g Cream vs CD5789 Vehicle Cream; p = 0.040; Percentage difference 16.393 (95% CI -0.249 to 33.036) NCT01616654 ↗

registry analysis (superiority test); CD5789 25 mcg/g Cream vs Vehicle Cream; p = 0.108; Percentage difference -6.74 (95% CI -14.96 to 1.48) NCT01616654 ↗

registry analysis (superiority test); CD5789 100 mcg/g Cream vs CD5789 Vehicle Cream; p = 0.038; Cochran-Mantel-Haenszel NCT01616654 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tazarotene Small molecule 0.1 % Topical
Subject Trifarotene Small molecule 25 unknown Topical
Subject Trifarotene Small molecule 50 unknown Topical
Subject Trifarotene Small molecule 100 unknown Topical

Indications