Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Summary

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

Conditions

• Rosacea

Interventions

DRUG

CD07805/47 Gel

CD07805/47 Gel 0.5% QD

DRUG

Vehicle Gel

Vehicle Gel QD

DRUG

CD07805/47 Gel

CD07805/47 Gel 0.18% QD

DRUG

CD07805/47 Gel

CD07805/47 Gel 0.18% BID

DRUG

Vehicle Gel

Vehicle Gel BID

Sponsors & Collaborators

• Galderma R&D

  lead INDUSTRY

Principal Investigators

• Michael Graeber, MD · Galderma R&D, Inc

• William Abramovits, MD · Dermatology Treatment & Research Center

• Fran Cook-Bolden, MD · Skin Specialty Group

• Zoe Draelos, MD · Dermatology Consulting Services, High Point NC

• Joseph Fowler, MD · Dermatology Specialists, PSC

• Kimberly Grande, MD · The Skin Wellness Center

• Michael Heffernan, MD · Central Dermatology PC

• Steven Kempers, MD · Minnesota Clinical Study Center

• Mark Ling, MD · Meda Phase, Inc.

• Robert Matheson, MD · Oregon Medical Research

• Kappa Meadows, MD · The Education & Research Foundation

• Angela Moore, MD · Arlington Center for Dermatology

• Girish Munavalli, MD · Dermatology, Laser & Vein Specialists of the Carolinas

• Andrew Pollack, MD · Philadelphia Institute of Dermatology

• Phoebe Rich, MD · Oregon Dermatology & Research Center

• Harry Sharta, MD · Madison Skin & Research

• Martin Steinhoff, MD · University of California at San Francisco

• Dow Stough, MD · Burke Pharmaceutical Research

• William Werschler, MD · Premier Clinical Research

• Patricia Westmoreland, MD · Palmetto Clinical Trial Services, LLC

• Stephen Schleicher, MD · DermDox

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2010-12-31

Completion

2011-01-31

Countries

• United States

Study Locations