Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

NCT ID: NCT01318733

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-07-31

Brief Summary

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Conditions

Rosacea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CD07805/47 Gel 0.5%

Group Type: EXPERIMENTAL

CD07805/47 gel 0.5%

Intervention Type: DRUG

In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.

Interventions

CD07805/47 gel 0.5%

In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female who is at least 18 years of age or older.
• A clinical diagnosis of facial rosacea.
• A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
• A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

Exclusion Criteria

• 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.
• 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.
• Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
• Current treatment with monoamine oxidase (MAO) inhibitors.
• Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
• Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

• 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

Scott Clark, MD

Role: PRINCIPAL_INVESTIGATOR

Longmont Clinical PC

Lesly Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

Palmetto Medical Research

Steven Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Clinical Research Center of San Antonio

Michael Donahue, MD

Role: PRINCIPAL_INVESTIGATOR

Wilmington Medical Research

Timothy Gardner, MD

Role: PRINCIPAL_INVESTIGATOR

East Tennessee Medical Research

Michael Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Tennessee Clinical Research Center

Fasahat Hamzavi, MD

Role: PRINCIPAL_INVESTIGATOR

Hamzavi Dermatology

Mark Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Progressive Clinicial Research, PA

Debra Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Medical Research

Keith Loven, MD

Role: PRINCIPAL_INVESTIGATOR

Rivergate Dermatology Clinical Research Center, PLLC

Michael Maloney, MD

Role: PRINCIPAL_INVESTIGATOR

Cherry Creek Research, Inc.

Angela Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Arlington Center for Dermatology

George Murakawa, MD

Role: PRINCIPAL_INVESTIGATOR

Dermcenter PC - Somerset Skin Centre

Catherine Pointon, MD

Role: PRINCIPAL_INVESTIGATOR

Metrolina Medical Research

Elyse Rafal, MD

Role: PRINCIPAL_INVESTIGATOR

DermResearch Center of NewYork, Inc.

Stephen Schleicher, MD

Role: PRINCIPAL_INVESTIGATOR

DermDox

Joel Schlessinger, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Specialists, PC

Leonard Swinyer, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Research Center

Amanda Tauscher, MD

Role: PRINCIPAL_INVESTIGATOR

Compliant Clinical Research

Gary Waterman, MD

Role: PRINCIPAL_INVESTIGATOR

Deaconess Clinic

Jonathan Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Gwinnett Clinical Research Center, Inc.

Morrissa Baskin, MD

Role: PRINCIPAL_INVESTIGATOR

Wenatchee Valley Medical Center, Clinical Research Department

Steven Kempers, MD

Role: PRINCIPAL_INVESTIGATOR

Minnesota Clinical Study Center

Ava Shamban, MD

Role: PRINCIPAL_INVESTIGATOR

The Laser Institute for Dermatology

Harry Sharata, MD

Role: PRINCIPAL_INVESTIGATOR

Madison Skin & Research, Inc.

Russell Mader, MD

Role: PRINCIPAL_INVESTIGATOR

TriCities Medical Research

Girish Munavalli, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology, Laser & Vein Specialists of the Carolinas

Locations

The Laser Institute for Dermatology

Santa Monica, California, United States

Cherry Creek Research, Inc

Denver, Colorado, United States

Longmont Clinical PC

Longmont, Colorado, United States

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, United States

Deaconess Clinic

Evansville, Indiana, United States

Compliant Clinical Research

Olathe, Kansas, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Dermcenter PC- Somerset Skin Centre

Troy, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Skin Specialists, PC

Omaha, Nebraska, United States

DermResearch Center of New York, Inc

Stony Brook, New York, United States

Metrolina Medical Research

Charlotte, North Carolina, United States

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, United States

Wilmington Medical Research

Wilmington, North Carolina, United States

Piedmont Medical Research

Winston-Salem, North Carolina, United States

DermDox

Hazleton, Pennsylvania, United States

Palmetto Medical Research

Mt. Pleasant, South Carolina, United States

Rivergate Dermatology Clinical Research Center, PLLC

Goodlettsville, Tennessee, United States

East Tennessee Medical Research

Johnson City, Tennessee, United States

TriCities Medical Research

Kingsport, Tennessee, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Arlington Center for Dermatology

Arlington, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Progressive Clinical Research, PA

San Antonio, Texas, United States

Dermatology Research Center

Salt Lake City, Utah, United States

Wenatchee Valley Medical Center - Clinical Research Department

Wenatchee, Washington, United States

Madison Skin & Research, Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

RD.06.SPR.18142

Identifier Type: -

Identifier Source: org_study_id