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

Rosacea Clinical Trial

Official title:

A Multicenter, Randomized Double-Blind, Vehicle-Controlled, Parallel Group Study to Demonstrate the Efficacy and Safety of CD07805/47 Gel Applied Topically Once Daily in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355458
• Other study ID #: RD.06.SPR.18140
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Related Conditions & MeSH terms

• Erythema
• Rosacea

Intervention

Drug:
• CD07805/47 gel
applied topically once daily
• Placebo
applied topically once daily

Locations

Country	Name	City	State
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Innovaderm Research, Inc	Montreal	Quebec
Canada	Windsor Clinical Research Inc.	Windsor	Ontario
United States	Arlington Center for Dermatology	Arlington	Texas
United States	DermResearch, Inc.	Austin	Texas
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Dermatology Treatment & Research Center	Dallas	Texas
United States	Windsor Dermatology	East Windsor	New Jersey
United States	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania
United States	Dermatology Consulting Services	High Point	North Carolina
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Dermatology Research Associates	Los Angeles	California
United States	The Education & Research Foundation, Inc.	Lynchburg	Virginia
United States	Oregon Medical Research Center	Portland	Oregon
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Success	Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).	Day 29