drugset / Trial / NCT02575950

Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne

NCT02575950 ↗

Phase 2 Completed 59 enrolled LEO Pharma
RandomizedParallel-groupDouble-blindTreatment

Summary

An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled, double-blinded, split-pace (left/right) design trial to evaluate the efficacy and tolerability of LEO 43204 in adults with moderate to severe acne.

Timeline

Start
2016-06
Primary completion
2017-04
Completion
2017-04

Outcome

Met primary endpoint

registry analysis (superiority test); LEO 43204 0.018% vs Vehicle; p <.001; Mean Difference (Final Values) -9.34 (95% CI -14.71 to -3.96); ANCOVA NCT02575950 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ingenol disoxate Small molecule 0.018 % —

Indications