Clinical trial NCT01355471: 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: 293
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: 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.


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: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Miami Beach
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: New York
country: United States
facility: Skin Specialty Dermatology
state: New York
city: South Euclid
country: United States
facility: Haber Dermatology & Cosmetic Surgery
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: College Station
country: United States
facility: J&S Studies Inc.
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Calgary
country: Canada
facility: Kirk Barber Research Inc.
state: Alberta
city: St John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Newlab Clinical Research Inc.
state: Newfoundland and Labrador
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_CHAIR
affiliation: Kirk Barber Research Inc.
name: Kirk Barber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baumann Cosmetic and Research Institute
name: Leslie Baumann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Specialty Dermatology
name: Fran Cook-Bolden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists PSC
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grekin Skin Institute
name: Steven Grekin, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Newlab Clinical Research Inc.
name: Wayne Gulliver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haber Dermatology & Cosmetic Surgery
name: Robert Haber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Dermatology
name: Michael Heffernan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: J&S Studies Inc.
name: Terry Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nexus Clinical Research
name: Ian Landells, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedaPhase, Inc.
name: Mark Ling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Dermatology and Research Center
name: Phoebe Rich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Burke Pharmaceutical Research
name: Dow Stough, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Clinical Research
name: William Werschler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmetto Clinical Trials Services, LLC
name: Patricia Westmoreland, MD
role: PRINCIPAL_INVESTIGATOR
References: