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:
NCT01174030
First received: July 30, 2010
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.


Condition Intervention Phase
Rosacea
Drug: CD07805/47 Gel
Drug: Vehicle Gel
Phase 2

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 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Composite Success [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

    Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).

    Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.



Secondary Outcome Measures:
  • CEA Success [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

    CEA success defined as 2-grade improvement on CEA.

    Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

    Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema

    1. / Amost clear; slight redness
    2. / Mild erythema; definite redness
    3. / Moderate erythema; marked redness
    4. / Severe erythema; fiery redness

  • PSA-5 Success [ Time Frame: day 29 ] [ Designated as safety issue: No ]

    Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

    PSA-5 success defined as 2-grade improvement on PSA-5.

    Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness

    1. / Very mild redness
    2. / Mild redness
    3. / Moderate redness
    4. / Severe redness


Enrollment: 269
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD07805/47 Gel 0.5% QD Drug: CD07805/47 Gel
CD07805/47 Gel 0.5% QD
Experimental: CD07805/47 Gel 0.18% QD Drug: CD07805/47 Gel
CD07805/47 Gel 0.18% QD
Experimental: CD07805/47 Gel 0.18% BID Drug: CD07805/47 Gel
CD07805/47 Gel 0.18% BID
Placebo Comparator: Vehicle Gel QD Drug: Vehicle Gel
Vehicle Gel QD
Placebo Comparator: Vehicle Gel BID Drug: Vehicle Gel
Vehicle Gel BID

  Eligibility

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

Inclusion Criteria:

  • Male or female, who is at least 18 years of age or older.
  • A clinical diagnosis of rosacea.
  • A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
  • A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
  • A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion Criteria:

  • Three (3) or more facial inflammatory lesions.
  • 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.
  • Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
  • Intraocular pressure (IOP) measurement less than 10 mm Hg.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174030

  Show 20 Study Locations
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma R&D, Inc
Principal Investigator: William Abramovits, MD Dermatology Treatment & Research Center
Principal Investigator: Fran Cook-Bolden, MD Skin Specialty Group
Principal Investigator: Zoe Draelos, MD Dermatology Consulting Services
Principal Investigator: Joseph Fowler, MD Dermatology Specialists, PSC
Principal Investigator: Kimberly Grande, MD The Skin Wellness Center
Principal Investigator: Michael Heffernan, MD Central Dermatology PC
Principal Investigator: Steven Kempers, MD Minnesota Clinical Study Center
Principal Investigator: Mark Ling, MD Meda Phase, Inc.
Principal Investigator: Robert Matheson, MD Oregon Medical Research
Principal Investigator: Kappa Meadows, MD The Education & Research Foundation
Principal Investigator: Angela Moore, MD Arlington Center for Dermatology
Principal Investigator: Girish Munavalli, MD Dermatology, Laser & Vein Specialists of the Carolinas
Principal Investigator: Andrew Pollack, MD Philadelphia Institute of Dermatology
Principal Investigator: Phoebe Rich, MD Oregon Dermatology & Research Center
Principal Investigator: Harry Sharta, MD Madison Skin & Research
Principal Investigator: Martin Steinhoff, MD University of California at San Francisco
Principal Investigator: Dow Stough, MD Burke Pharmaceutical Research
Principal Investigator: William Werschler, MD Premier Clinical Research
Principal Investigator: Patricia Westmoreland, MD Palmetto Clinical Trial Services, LLC
Principal Investigator: Stephen Schleicher, MD DermDox
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01174030     History of Changes
Other Study ID Numbers: RD.06.SPR.18161
Study First Received: July 30, 2010
Results First Received: September 19, 2013
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014