Clinical trial NCT01355458: Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Keywords: rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Composite Success
timeFrame: Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: East Windsor
country: United States
facility: Windsor Dermatology
state: New Jersey
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Fort Washington
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research, Inc
state: Quebec
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_CHAIR
affiliation: Dermatology Treatment & Research Center
name: William Abramovits, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovaderm Research Inc.
name: Robert Bissonette, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Consulting Services, High Point NC
name: Zoe Draelos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Skin Wellness Center
name: Kimberly Grande, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derm Research, PLLC
name: Michael Jarratt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lynderm Research Inc
name: Charles Lynde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Medical Research Center
name: Robert Matheson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Education & Research Foundation, Inc.
name: Kappa Meadows, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arlington Center for Dermatology
name: Angela Moore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Windsor Dermatology
name: David Nieves, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philadelphia Institute of Dermatology
name: Andrew Pollack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Research Associates
name: Howard Sofen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Martin Steinhoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Center for Skin Care Research
name: Daniel Stewart, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Windsor Clinical Research Inc.
name: Jerry Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: