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

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

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.

Study Overview

• Status: Completed
• Conditions: Erythematotelangiectatic Rosacea
• Intervention / Treatment: Drug: CD07805/47; Drug: CD07805/47; Drug: CD07805/47; Drug: CD07805/47 placebo

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • Philadephia Institute of Dermatology
  • Texas
    • Austin, Texas, United States, 78759
      • Derm Research, Inc
    • College Station, Texas, United States, 77845
      • J&S Studies
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education & Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CD07805/47 0.5% Topical Gel; 0.5% Topical Gel	Drug: CD07805/47; 0.5% Topical Gel; Drug: CD07805/47; 0.18% Topical Gel; Drug: CD07805/47; 0.07% Topical Gel
EXPERIMENTAL: CD07805/47 0.18% Topical Gel; 0.18% Topical Gel	Drug: CD07805/47; 0.5% Topical Gel; Drug: CD07805/47; 0.18% Topical Gel; Drug: CD07805/47; 0.07% Topical Gel
EXPERIMENTAL: CD07805/47 0.07% Topical Gel; 0.07% Topical Gel	Drug: CD07805/47; 0.5% Topical Gel; Drug: CD07805/47; 0.18% Topical Gel; Drug: CD07805/47; 0.07% Topical Gel
PLACEBO_COMPARATOR: CD07805/47 Vehicle Topical Gel; Vehicle Topical Gel	Drug: CD07805/47 placebo; Vehicle Topical Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: October 1, 2009
• First Posted (ESTIMATE): October 2, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Rosacea; Erythematotelangiectatic
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: RD.06.SPR.18144