Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
- Conditions
- Rosacea
- Interventions
- Drug: CD07805/47 gel 0.5%
- Registration Number
- NCT01318733
- Lead Sponsor
- Galderma R&D
- Brief Summary
A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 449
- 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 ≥3 at Screening and at Baseline (prior to study drug application).
- A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).
- 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.
- 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.
- Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
- Current treatment with monoamine oxidase (MAO) inhibitors.
- Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
- Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CD07805/47 Gel 0.5% CD07805/47 gel 0.5% -
- Primary Outcome Measures
Name Time Method Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. Over 1 year Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
1. / Almost clear; slight redness
2. / Mild erythema; definite redness
3. / Moderate erythema; marked redness
4. / Severe erythema; fiery redness
Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
DermResearch Center of New York, Inc
🇺🇸Stony Brook, New York, United States
Rivergate Dermatology Clinical Research Center, PLLC
🇺🇸Goodlettsville, Tennessee, United States
Wenatchee Valley Medical Center - Clinical Research Department
🇺🇸Wenatchee, Washington, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
Gwinnett Clinical Research Center, Inc
🇺🇸Snellville, Georgia, United States
Wilmington Medical Research
🇺🇸Wilmington, North Carolina, United States
East Tennessee Medical Research
🇺🇸Johnson City, Tennessee, United States
Cherry Creek Research, Inc
🇺🇸Denver, Colorado, United States
The Laser Institute for Dermatology
🇺🇸Santa Monica, California, United States
Compliant Clinical Research
🇺🇸Olathe, Kansas, United States
Dermatology, Laser & Vein Specialists of the Carolinas
🇺🇸Charlotte, North Carolina, United States
Palmetto Medical Research
🇺🇸Mount Pleasant, South Carolina, United States
Madison Skin & Research, Inc.
🇺🇸Madison, Wisconsin, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
TriCities Medical Research
🇺🇸Kingsport, Tennessee, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Longmont Clinical PC
🇺🇸Longmont, Colorado, United States
Deaconess Clinic
🇺🇸Evansville, Indiana, United States
Dermcenter PC- Somerset Skin Centre
🇺🇸Troy, Michigan, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
DermDox
🇺🇸Hazleton, Pennsylvania, United States
Arlington Center for Dermatology
🇺🇸Arlington, Texas, United States
Dermatology Research Center
🇺🇸Salt Lake City, Utah, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States