Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
- Conditions
- Rosacea
- Interventions
- Drug: CD07805/47 GelDrug: Placebo
- Registration Number
- NCT01355471
- Lead Sponsor
- Galderma R&D
- Brief Summary
This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 293
- Male or female who is at least 18 years of age or older.
- A clinical diagnosis of facial rosacea.
- A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
- A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
Key
- 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.
- Presence of three (3) or more facial inflammatory lesions of rosacea.
- Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
- Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
- Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CD07805/47 gel CD07805/47 Gel - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Composite Success Day 29 Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Haber Dermatology & Cosmetic Surgery
🇺🇸South Euclid, Ohio, United States
Central Dermatology PC
🇺🇸Saint Louis, Missouri, United States
Skin Specialty Dermatology
🇺🇸New York, New York, United States
Kirk Barber Research Inc.
🇨🇦Calgary, Alberta, Canada
Baumann Cosmetic and Research Institute
🇺🇸Miami Beach, Florida, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Newlab Clinical Research Inc.
🇨🇦St. John's, Newfoundland and Labrador, Canada
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
MedaPhase, Inc.
🇺🇸Newnan, Georgia, United States
Nexus Clinical Research
🇨🇦St John's, Newfoundland and Labrador, Canada
J&S Studies Inc.
🇺🇸College Station, Texas, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Greenville, South Carolina, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States