Status:
COMPLETED
Effect of CD07805/47 Gel in Rosacea Flushing
Lead Sponsor:
Galderma R&D
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of the flush of rosacea.
Detailed Description
The objectives of this study in rosacea patients (type I\&II) are: * to demonstrate objectively that CD07805/47 0.5% gel is able to prevent a flush induced by a specific trigger (hot water) in contro...
Eligibility Criteria
Inclusion
- The subject is a male or female, who is at least 18 years of age or older at Screening visit.
- The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea or mild to moderate papulo-pustular rosacea according to the National Rosacea Society grading (Wilkin et al., 2004)
- The subject had at least five flushing episodes during the last week before Screening and Baseline visits
Exclusion
- 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;
- The subject has current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;
- The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02300129
Start Date
April 1 2014
End Date
June 1 2014
Last Update
October 20 2016
Active Locations (1)
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1
Galderma Investigational site
Hamburg, Germany