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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Erythematotelangiectatic Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CD07805/47 0.5% Topical Gel

0.5% Topical Gel

Group Type EXPERIMENTAL

CD07805/47

Intervention Type DRUG

0.5% Topical Gel

CD07805/47 0.18% Topical Gel

0.18% Topical Gel

Group Type EXPERIMENTAL

CD07805/47

Intervention Type DRUG

0.18% Topical Gel

CD07805/47 0.07% Topical Gel

0.07% Topical Gel

Group Type EXPERIMENTAL

CD07805/47

Intervention Type DRUG

0.07% Topical Gel

CD07805/47 Vehicle Topical Gel

Vehicle Topical Gel

Group Type PLACEBO_COMPARATOR

CD07805/47 placebo

Intervention Type DRUG

Vehicle Topical Gel

Interventions

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CD07805/47

0.5% Topical Gel

Intervention Type DRUG

CD07805/47

0.18% Topical Gel

Intervention Type DRUG

CD07805/47

0.07% Topical Gel

Intervention Type DRUG

CD07805/47 placebo

Vehicle Topical Gel

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No