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

NCT ID: NCT01355458

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-12-31

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CD07805/47 gel

Group Type: EXPERIMENTAL

CD07805/47 gel

Intervention Type: DRUG

applied topically once daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

applied topically once daily

Interventions

CD07805/47 gel

applied topically once daily

Intervention Type: DRUG

Placebo

applied topically once daily

Intervention Type: DRUG

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Graeber, MD

Role: STUDY_CHAIR

Galderma R&D

William Abramovits, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Treatment & Research Center

Robert Bissonette, MD

Role: PRINCIPAL_INVESTIGATOR

Innovaderm Research Inc.

Zoe Draelos, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Consulting Services, High Point NC

Kimberly Grande, MD

Role: PRINCIPAL_INVESTIGATOR

The Skin Wellness Center

Michael Jarratt, MD

Role: PRINCIPAL_INVESTIGATOR

Derm Research, PLLC

Charles Lynde, MD

Role: PRINCIPAL_INVESTIGATOR

Lynderm Research Inc

Robert Matheson, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Medical Research Center

Kappa Meadows, MD

Role: PRINCIPAL_INVESTIGATOR

The Education & Research Foundation, Inc.

Angela Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Arlington Center for Dermatology

David Nieves, MD

Role: PRINCIPAL_INVESTIGATOR

Windsor Dermatology

Andrew Pollack, MD

Role: PRINCIPAL_INVESTIGATOR

Philadelphia Institute of Dermatology

Howard Sofen, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Research Associates

Martin Steinhoff, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Daniel Stewart, DO

Role: PRINCIPAL_INVESTIGATOR

Michigan Center for Skin Care Research

Jerry Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Windsor Clinical Research Inc.

Locations

Dermatology Research Associates

Los Angeles, California, United States

University of California, San Francisco

San Francisco, 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

Oregon Medical Research Center

Portland, Oregon, United States

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, United States

The Skin Wellness Center

Knoxville, Tennessee, United States

Arlington Center for Dermatology

Arlington, Texas, United States

DermResearch, Inc.

Austin, Texas, United States

Dermatology Treatment & Research Center

Dallas, 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

Innovaderm Research, Inc

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

RD.06.SPR.18140

Identifier Type: -

Identifier Source: org_study_id