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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014