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

Galderma

Status and phase: Completed; Phase 2

Conditions: Erythematotelangiectatic Rosacea

Treatments: Drug: CD07805/47 placebo; Drug: CD07805/47

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989014

RD.06.SPR.18144

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 4 patient groups, including a placebo group

CD07805/47 0.5% Topical Gel

Experimental group

Description:

0.5% Topical Gel

Treatment:

Drug: CD07805/47

Drug: CD07805/47

Drug: CD07805/47

CD07805/47 0.18% Topical Gel

Experimental group

Description:

0.18% Topical Gel

Treatment:

Drug: CD07805/47

Drug: CD07805/47

Drug: CD07805/47

CD07805/47 0.07% Topical Gel

Experimental group

Description:

0.07% Topical Gel

Treatment:

Drug: CD07805/47

Drug: CD07805/47

Drug: CD07805/47

CD07805/47 Vehicle Topical Gel

Placebo Comparator group

Description:

Vehicle Topical Gel

Treatment:

Drug: CD07805/47 placebo