Phase 2
N=122
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
Erythematotelangiectatic Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT00989014 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. — 17; 10; 7; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CD07805/47 (Drug); CD07805/47 placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. |
17; 10; 7; 4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00989014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.