Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300129
• Other study ID #: RD.03.SPR.40225E
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2014
• Last updated: November 21, 2014
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

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

Intervention

Drug:
• CD07805/47 0.5% gel (Brimonidine tartrate)
Experimental product
• CD07805/47 gel placebo
Placebo

Locations

Country	Name	City	State
Germany	Galderma Investigational site	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of flushes for each 2-week period		Day 22 and Day 36/Early termination	No