Rosacea Clinical Trial - Effect of CD07805/47 Gel in Rosacea Flushing

Status Completed

Clinical Trial Summary

Phase IIa study to assess the efficacy and safety of CD07805/47 0.5% gel in the treatment of the flush of rosacea.

Clinical Trial Description

This is a single-centre, randomized, Investigator masked, placebo controlled study comprising the following 2 parts.

During the part I of study, 36 subjects will receive on site the following treatments during one week (the order of each session being randomized) under intra-individual design:

- placebo on both sides of the face,

- one side of the face treated with CD07805/47 0.5% gel, the other side treated with placebo (the allocation of treatment on each half-face will be determined according to a randomization list),

- CD07805/47 0.5% gel on both sides of the face;

During the part II of study, the same subjects will receive during 4 weeks the following treatments on the whole face (once a day 7 days a week, at home) in parallel groups:

- 18 subjects will receive the CD07805/47 0.5% gel the first 2 weeks and then the placebo and;

- 18 subjects will receive the placebo the first 2 weeks and then the CD07805/47 0.5% gel, according to randomization. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Rosacea

Clinical Trial Details

NCT number	NCT02300129
Study type	Interventional
Source	Galderma R&D
Contact
Status	Completed
Phase	Phase 2
Start date	April 2014
Completion date	June 2014

View Details

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