CompletedPhase 2

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

United States122 participantsStarted 2009-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.

Timeframe: Baseline and every hour for 12 hours following application

Trial details

NCT IDNCT00989014

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2013-09-19