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

Phase 2

Completed

• Conditions: Erythematotelangiectatic Rosacea
• Interventions: Drug: CD07805/47; Drug: CD07805/47 placebo

• Registration Number: NCT00989014
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Disposition First Submitted: 2010-10-16
• Disposition First Submitted QC: 2010-12-02
• Disposition First Posted: 2010-12-06
• Status Verified: 2013-09
• Results First Submitted: 2013-09-19
• Results First Submitted QC: 2013-09-19
• Results First Posted: 2013-11-21
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD07805/47 0.18% Topical Gel	CD07805/47	0.18% Topical Gel
CD07805/47 Vehicle Topical Gel	CD07805/47 placebo	Vehicle Topical Gel
CD07805/47 0.5% Topical Gel	CD07805/47	0.5% Topical Gel
CD07805/47 0.07% Topical Gel	CD07805/47	0.07% Topical Gel

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Derm Research, Inc; 🇺🇸 Austin, Texas, United States

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arkansas, United States

The Education & Research Foundation; 🇺🇸 Lynchburg, Virginia, United States

Philadephia Institute of Dermatology; 🇺🇸 Fort Washington, Pennsylvania, United States

J&S Studies; 🇺🇸 College Station, Texas, United States