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

Sponsor:	Galderma
Information provided by (Responsible Party):	Galderma
ClinicalTrials.gov Identifier:	NCT01355471

Purpose

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	Intervention	Phase
Rosacea	Drug: CD07805/47 Gel Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

Composite Success [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

Secondary Outcome Measures:

30 Minutes Effect [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.

Enrollment:	293
Study Start Date:	May 2011
Study Completion Date:	January 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CD07805/47 gel	Drug: CD07805/47 Gel applied topically once daily
Placebo Comparator: Placebo	Drug: Placebo applied topically once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key 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 greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
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:

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.
Presence of three (3) or more facial inflammatory lesions of rosacea.
Current treatment with monoamine oxidase (MAO) inhibitors, 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.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355471

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
St. 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

Investigators

Study Chair:	Michael Graeber, MD	Galderma
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

No publications provided

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT01355471 History of Changes
Other Study ID Numbers:	RD.06.SPR.18141
Study First Received:	May 16, 2011
Last Updated:	February 15, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Galderma:

rosacea

Additional relevant MeSH terms:

Rosacea
Erythema
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2012