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

NCT ID: NCT01355471

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 293 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-01-31

Brief 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.

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

Kirk Barber, MD

Role: PRINCIPAL_INVESTIGATOR

Kirk Barber Research Inc.

Leslie Baumann, MD

Role: PRINCIPAL_INVESTIGATOR

Baumann Cosmetic and Research Institute

Fran Cook-Bolden, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Specialty Dermatology

Joseph Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists PSC

Steven Grekin, DO

Role: PRINCIPAL_INVESTIGATOR

Grekin Skin Institute

Wayne Gulliver, MD

Role: PRINCIPAL_INVESTIGATOR

Newlab Clinical Research Inc.

Robert Haber, MD

Role: PRINCIPAL_INVESTIGATOR

Haber Dermatology & Cosmetic Surgery

Michael Heffernan, MD

Role: PRINCIPAL_INVESTIGATOR

Central Dermatology

Terry Jones, MD

Role: PRINCIPAL_INVESTIGATOR

J&S Studies Inc.

Ian Landells, MD

Role: PRINCIPAL_INVESTIGATOR

Nexus Clinical Research

Mark Ling, MD

Role: PRINCIPAL_INVESTIGATOR

MedaPhase, Inc.

Phoebe Rich, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Dermatology and Research Center

Dow Stough, MD

Role: PRINCIPAL_INVESTIGATOR

Burke Pharmaceutical Research

William Werschler, MD

Role: PRINCIPAL_INVESTIGATOR

Premier Clinical Research

Patricia Westmoreland, MD

Role: PRINCIPAL_INVESTIGATOR

Palmetto Clinical Trials Services, LLC

Locations

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Baumann Cosmetic and Research Institute

Miami Beach, Florida, United States

MedaPhase, Inc.

Newnan, Georgia, United States

Dermatology Specialists Research

Louisville, Kentucky, United States

Grekin Skin Institute

Warren, Michigan, United States

Central Dermatology PC

St Louis, Missouri, United States

Skin Specialty Dermatology

New York, New York, United States

Haber Dermatology & Cosmetic Surgery

South Euclid, Ohio, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, United States

J&S Studies Inc.

College Station, Texas, United States

Premier Clinical Research

Spokane, Washington, United States

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, Canada

Countries

United States; Canada

Other Identifiers

RD.06.SPR.18141

Identifier Type: -

Identifier Source: org_study_id