Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT00989014
First received: September 30, 2009
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.


Condition Intervention Phase
Erythematotelangiectatic Rosacea
Drug: CD07805/47
Drug: CD07805/47 placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. [ Time Frame: Baseline and every hour for 12 hours following application ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD07805/47 0.5% Topical Gel
0.5% Topical Gel
Drug: CD07805/47
0.5% Topical Gel
Experimental: CD07805/47 0.18% Topical Gel
0.18% Topical Gel
Drug: CD07805/47
0.18% Topical Gel
Experimental: CD07805/47 0.07% Topical Gel
0.07% Topical Gel
Drug: CD07805/47
0.07% Topical Gel
Placebo Comparator: CD07805/47 Vehicle Topical Gel
Vehicle Topical Gel
Drug: CD07805/47 placebo
Vehicle Topical Gel

  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.
  • Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
  • CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
  • PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
  • Presence of 2 or fewer inflammatory facial lesions.

Exclusion Criteria:

  • History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
  • History of refractive surgery such as photorefractive keratectomy.
  • The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
  • The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989014

Locations
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, Pennsylvania
Philadephia Institute of Dermatology
Fort Washington, Pennsylvania, United States, 19034
United States, Texas
Derm Research, Inc
Austin, Texas, United States, 78759
J&S Studies
College Station, Texas, United States, 77845
United States, Virginia
The Education & Research Foundation
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00989014     History of Changes
Other Study ID Numbers: RD.06.SPR.18144
Study First Received: September 30, 2009
Results First Received: September 19, 2013
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
Erythematotelangiectatic
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on April 14, 2014