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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01355471
First received: May 16, 2011
Last updated: September 19, 2013
Last verified: September 2013

May 16, 2011
September 19, 2013
May 2011
November 2011   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01355471 on ClinicalTrials.gov Archive Site
Not Provided
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.
Not Provided
Not Provided
 
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rosacea
  • Drug: CD07805/47 Gel
    applied topically once daily
  • Drug: Placebo
    applied topically once daily
  • Experimental: CD07805/47 gel
    Intervention: Drug: CD07805/47 Gel
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
293
January 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01355471
RD.06.SPR.18141
No
Galderma
Galderma
Not Provided
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
Galderma
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP