Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

Summary

This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Timeline

Start

2015-12

Primary completion

2017-07-05

Completion

2018-04-13

Outcome

Met primary endpoint

registry analysis (superiority test); Treatment vs Vehicle Gel; p = 0.043; ANCOVA NCT02547441 ↗

registry analysis (superiority test); Treatment vs Vehicle Gel; p = 0.019; Cochran-Mantel-Haenszel NCT02547441 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omiganan	Protein / enzyme biologic	—	Topical

Indications