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
Overview
- Phase
- Phase 2
- Intervention
- CD07805/47
- Conditions
- Erythematotelangiectatic Rosacea
- Sponsor
- Galderma R&D
- Enrollment
- 122
- Locations
- 5
- Primary Endpoint
- Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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.
Arms & Interventions
CD07805/47 0.5% Topical Gel
0.5% Topical Gel
Intervention: CD07805/47
CD07805/47 0.18% Topical Gel
0.18% Topical Gel
Intervention: CD07805/47
CD07805/47 0.07% Topical Gel
0.07% Topical Gel
Intervention: CD07805/47
CD07805/47 Vehicle Topical Gel
Vehicle Topical Gel
Intervention: CD07805/47 placebo
Outcomes
Primary Outcomes
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