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: NCT01355471
• Other study ID #: RD.06.SPR.18141
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Est. completion date: January 2012

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: January 2012
• Est. primary completion date: November 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	Kirk Barber Research Inc.	Calgary	Alberta
Canada	Nexus Clinical Research	St John's	Newfoundland and Labrador
Canada	Newlab Clinical Research Inc.	St. John's	Newfoundland and Labrador
United States	J&S Studies Inc.	College Station	Texas
United States	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	Baumann Cosmetic and Research Institute	Miami Beach	Florida
United States	Skin Specialty Dermatology	New York	New York
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Central Dermatology PC	Saint Louis	Missouri
United States	Haber Dermatology & Cosmetic Surgery	South Euclid	Ohio
United States	Premier Clinical Research	Spokane	Washington
United States	Grekin Skin Institute	Warren	Michigan

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