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

• ClinicalTrials.gov Identifier: NCT01355471
• Recruitment Status: Completed
• First Posted: May 18, 2011
• Results First Posted: November 21, 2013
• Last Update Posted: February 18, 2021
• Sponsor: Galderma R&D
• Information provided by (Responsible Party): Galderma R&D

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rosacea	Drug: CD07805/47 Gel; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 293 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 2011
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: CD07805/47 gel	Drug: CD07805/47 Gel; applied topically once daily
Placebo Comparator: Placebo	Drug: Placebo; applied topically once daily

Outcome Measures

Primary Outcome Measures :

1. Composite Success [ Time Frame: Day 29 ]
   Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Arkansas

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States, 71913

United States, Florida

Baumann Cosmetic and Research Institute

Miami Beach, Florida, United States, 33140

United States, Georgia

MedaPhase, Inc.

Newnan, Georgia, United States, 30263

United States, Kentucky

Dermatology Specialists Research

Louisville, Kentucky, United States, 40202

United States, Michigan

Grekin Skin Institute

Warren, Michigan, United States, 48088

United States, Missouri

Central Dermatology PC

Saint Louis, Missouri, United States, 63117

United States, New York

Skin Specialty Dermatology

New York, New York, United States, 10155

United States, Ohio

Haber Dermatology & Cosmetic Surgery

South Euclid, Ohio, United States, 44118

United States, Oregon

Oregon Dermatology and Research Center

Portland, Oregon, United States, 97210

United States, South Carolina

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, United States, 29607

United States, Texas

J&S Studies Inc.

College Station, Texas, United States, 77845

United States, Washington

Premier Clinical Research

Spokane, Washington, United States, 99201

Canada, Alberta

Kirk Barber Research Inc.

Calgary, Alberta, Canada, T25 3B3

Canada, Newfoundland and Labrador

Nexus Clinical Research

St John's, Newfoundland and Labrador, Canada, A1A 5E8

Newlab Clinical Research Inc.

St. John's, Newfoundland and Labrador, Canada, A1C2H5

Sponsors and Collaborators

Galderma R&D

Investigators

• Study Chair: Michael Graeber, MD; Galderma R&D
• Principal Investigator: Kirk Barber, MD; Kirk Barber Research Inc.
• Principal Investigator: Leslie Baumann, MD; Baumann Cosmetic and Research Institute
• Principal Investigator: Fran Cook-Bolden, MD; Skin Specialty Dermatology
• Principal Investigator: Joseph Fowler, MD; Dermatology Specialists PSC
• Principal Investigator: Steven Grekin, DO; Grekin Skin Institute
• Principal Investigator: Wayne Gulliver, MD; Newlab Clinical Research Inc.
• Principal Investigator: Robert Haber, MD; Haber Dermatology & Cosmetic Surgery
• Principal Investigator: Michael Heffernan, MD; Central Dermatology
• Principal Investigator: Terry Jones, MD; J&S Studies Inc.
• Principal Investigator: Ian Landells, MD; Nexus Clinical Research
• Principal Investigator: Mark Ling, MD; MedaPhase, Inc.
• Principal Investigator: Phoebe Rich, MD; Oregon Dermatology and Research Center
• Principal Investigator: Dow Stough, MD; Burke Pharmaceutical Research
• Principal Investigator: William Werschler, MD; Premier Clinical Research
• Principal Investigator: Patricia Westmoreland, MD; Palmetto Clinical Trials Services, LLC

More Information

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01355471
• Other Study ID Numbers: RD.06.SPR.18141
• First Posted: May 18, 2011
• Results First Posted: November 21, 2013
• Last Update Posted: February 18, 2021
• Last Verified: September 2013

Keywords provided by Galderma R&D:

rosacea

Additional relevant MeSH terms:

Rosacea; Erythema; Skin Diseases; Skin Manifestations