Effect of CD07805/47 Gel in Rosacea Flushing

Condition(s) targeted: Rosacea

Intervention: CD07805/47 0.5% gel (Brimonidine tartrate) (Drug); CD07805/47 gel placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Galderma R&D

Phase IIa study to assess the efficacy and safety of CD07805/47 0. 5% gel in the treatment of the flush of rosacea.

Official title: Effect of CD07805/47 Gel in Subjects Presenting With Flushing Related to Erythematotelangiectatic or Papulopustular Rosacea

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

Primary outcome: Total number of flushes for each 2-week period

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. The subject is a male or female, who is at least 18 years of age or older at Screening visit. 2. The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea (ETR) or mild to moderate papulo-pustular rosacea (PPR) according to the National Rosacea Society grading (Wilkin et al., 2004). 3. The subject had at least five flushing episodes during the last week before Screening and Baseline visits Exclusion Criteria: 1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin), or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus or actinic telangiectasia; 2. The subject has current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists; 3. The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;

Galderma Investigational site, Hamburg, Germany

Starting date: April 2014
Last updated: November 21, 2014