Patient-Reported Outcome Of Facial Erythema (PROOF)

Summary

The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.

Timeline

Start

2013-07-01

Primary completion

2013-11-14

Completion

2013-11-14

Outcome

Mixed primary results

registry analysis (superiority test); Brimonidine Tartrate 0.5% Gel vs Vehicle; p = 0.0065; Cochran-Mantel-Haenszel NCT01885000 ↗

registry NUMBER Brimonidine Tartrate 0.5% Gel: 69.6 Percentage of participants NCT01885000 ↗

registry NUMBER Vehicle: 40.4 Percentage of participants NCT01885000 ↗

registry analysis (superiority test); Brimonidine Tartrate 0.5% Gel vs Vehicle; p = 0.5312; Cochran-Mantel-Haenszel NCT01885000 ↗

registry analysis (superiority test); Brimonidine Tartrate 0.5% Gel vs Vehicle; p = 0.5821; Cochran-Mantel-Haenszel NCT01885000 ↗

registry analysis (superiority test); Brimonidine Tartrate 0.5% Gel vs Vehicle; p = 0.3935; Cochran-Mantel-Haenszel NCT01885000 ↗

registry analysis (superiority test); Brimonidine Tartrate 0.5% Gel vs Vehicle; p = 0.4162; Cochran-Mantel-Haenszel NCT01885000 ↗

Publications

• Layton AM, Schaller M, Homey B, Hofmann MA, Bewley AP, Lehmann P, Nohlgard C, Sarwer DB, Kerrouche N, Ma YM. Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study. J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2405-10. doi: 10.1111/jdv.13305. Epub 2015 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brimonidine	Unknown	0.5 %	Topical

Indications