Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Phase 3

Completed

• Conditions: Rosacea
• Interventions: Drug: CD07805/47 gel; Drug: Placebo

• Registration Number: NCT01355458
• Lead Sponsor: Galderma R&D

Brief Summary

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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Disposition First Submitted: 2012-07-23
• Disposition First Submitted QC: 2012-07-23
• Disposition First Posted: 2012-07-31
• Status Verified: 2013-09
• Results First Submitted: 2013-09-19
• Results First Submitted QC: 2013-09-19
• Results First Posted: 2013-11-21
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Male or female who is at least 18 years of age or older.
2. A clinical diagnosis of facial rosacea.
3. 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).
4. 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

Exclusion Criteria

1. 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. Presence of three (3) or more facial inflammatory lesions of rosacea.
3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
5. 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).

Trial Locations

Locations (15)

Oregon Medical Research Center; 🇺🇸 Portland, Oregon, United States

Innovaderm Research, Inc; 🇨🇦 Montreal, Quebec, Canada

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

The Skin Wellness Center; 🇺🇸 Knoxville, Tennessee, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Michigan Center for Skin Care Research; 🇺🇸 Clinton Township, Michigan, United States

Windsor Dermatology; 🇺🇸 East Windsor, New Jersey, United States

Dermatology Consulting Services; 🇺🇸 High Point, North Carolina, United States

Arlington Center for Dermatology; 🇺🇸 Arlington, Texas, United States

Philadelphia Institute of Dermatology; 🇺🇸 Fort Washington, Pennsylvania, United States

Dermatology Treatment & Research Center; 🇺🇸 Dallas, Texas, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

The Education & Research Foundation, Inc.; 🇺🇸 Lynchburg, Virginia, United States

Lynderm Research Inc; 🇨🇦 Markham, Ontario, Canada

Windsor Clinical Research Inc.; 🇨🇦 Windsor, Ontario, Canada