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

Summary

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

• William Abramovits, MD · Dermatology Treatment & Research Center

• Robert Bissonette, MD · Innovaderm Research Inc.

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

• Kimberly Grande, MD · The Skin Wellness Center

• Michael Jarratt, MD · Derm Research, PLLC

• Charles Lynde, MD · Lynderm Research Inc

• Robert Matheson, MD · Oregon Medical Research Center

• Kappa Meadows, MD · The Education & Research Foundation, Inc.

• Angela Moore, MD · Arlington Center for Dermatology

• David Nieves, MD · Windsor Dermatology

• Andrew Pollack, MD · Philadelphia Institute of Dermatology

• Howard Sofen, MD · Dermatology Research Associates

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

• Daniel Stewart, DO · Michigan Center for Skin Care Research

• Jerry Tan, MD · Windsor Clinical Research Inc.

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

2011-09-30

Completion

2011-12-31

Countries

• United States
• Canada

Study Locations