Clinical Endpoint Study of Ivermectin 1% Cream

Summary

A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of moderate to severe papulopustular rosacea.

Timeline

Start

2016-06

Primary completion

2016-11

Completion

2016-12

Outcome

Met primary endpoint

registry analysis (equivalence test); Ivermectin Cream, 1% vs SoolantraTM (Ivermectin) Cream, 1%; Mean Difference (Net) 103.51 (90% CI 97.95 to 110.00) NCT02840461 ↗

registry analysis (superiority test); Ivermectin Cream, 1% vs Vehicle Cream; p = 0.0027; Mean Difference (Net) -9.83 (95% CI -16.24 to -3.42); ANOVA NCT02840461 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivermectin	Small molecule	1 %	—

Indications