drugset / Trial / NCT03075891

Oracea Soolantra Association in Participants With Severe Rosacea

NCT03075891 ↗

Phase 4 Completed 273 enrolled Galderma R&D
RandomizedParallel-groupDouble-blindTreatment

Summary

The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea.

Timeline

Start
2017-07-05
Primary completion
2018-02-08
Completion
2018-02-08

Outcome

Met primary endpoint

registry analysis (superiority test); Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules vs Ivermectin 1% Cream + Oral Placebo Capsules; p = 0.032; Cochran-Mantel-Haenszel NCT03075891 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule 40 mg —
Background Ivermectin Small molecule 1 % Topical

Indications