Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Summary

This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.

Conditions

• Rosacea

Interventions

DRUG

CD07805/47 Gel

applied topically once daily

DRUG

Placebo

applied topically once daily

Sponsors & Collaborators

• Galderma R&D

  lead INDUSTRY

Principal Investigators

• Michael Graeber, MD · Galderma R&D

• Kirk Barber, MD · Kirk Barber Research Inc.

• Leslie Baumann, MD · Baumann Cosmetic and Research Institute

• Fran Cook-Bolden, MD · Skin Specialty Dermatology

• Joseph Fowler, MD · Dermatology Specialists PSC

• Steven Grekin, DO · Grekin Skin Institute

• Wayne Gulliver, MD · Newlab Clinical Research Inc.

• Robert Haber, MD · Haber Dermatology & Cosmetic Surgery

• Michael Heffernan, MD · Central Dermatology

• Terry Jones, MD · J&S Studies Inc.

• Ian Landells, MD · Nexus Clinical Research

• Mark Ling, MD · MedaPhase, Inc.

• Phoebe Rich, MD · Oregon Dermatology and Research Center

• Dow Stough, MD · Burke Pharmaceutical Research

• William Werschler, MD · Premier Clinical Research

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2011-11-30

Completion

2012-01-31

Countries

• United States
• Canada

Study Locations