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

Completed · Phase 2 · Has a placebo group

Conditions studied: Erythematotelangiectatic Rosacea

In brief

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.

Key facts

Study ID

NCT00989014

Run by

Galderma R&D

People needed

122

Starts

2009-09-01

Expected to finish

2009-12-01

Last updated by the study team

2021-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Philadephia Institute of Dermatology — Fort Washington, Pennsylvania, United States
• Derm Research, Inc — Austin, Texas, United States
• J&S Studies — College Station, Texas, United States
• The Education & Research Foundation — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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