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

Erythematotelangiectatic Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989014
• Other study ID #: RD.06.SPR.18144
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2013
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erythematotelangiectatic Rosacea
• Rosacea

Intervention

Drug:
• CD07805/47
0.5% Topical Gel
• CD07805/47
0.18% Topical Gel
• CD07805/47
0.07% Topical Gel
• CD07805/47 placebo
Vehicle Topical Gel

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.		Baseline and every hour for 12 hours following application