Clinical trial NCT00989014: Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
Official title: Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erythematotelangiectatic Rosacea
Keywords: Erythematotelangiectatic
Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Fort Washington
country: United States
facility: Philadephia Institute of Dermatology
state: Pennsylvania
city: Austin
country: United States
facility: Derm Research, Inc
state: Texas
city: College Station
country: United States
facility: J&S Studies
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation
state: Virginia
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References: