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

NCT01174030 | Completed Phase 2 Results

• 1 other identifier: RD.06.SPR.18161
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 20

Brief 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

Outcome Measures

Primary Outcomes (1)

• Composite Success

  Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.

  Day 29

Secondary Outcomes (2)

• CEA Success

  Day 29

• PSA-5 Success

  day 29

Study Arms (5)

CD07805/47 Gel 0.5% QD

EXPERIMENTAL

Drug: CD07805/47 Gel

CD07805/47 Gel 0.18% QD

EXPERIMENTAL

Drug: CD07805/47 Gel

CD07805/47 Gel 0.18% BID

EXPERIMENTAL

Drug: CD07805/47 Gel

Vehicle Gel QD

PLACEBO COMPARATOR

Drug: Vehicle Gel

Vehicle Gel BID

PLACEBO COMPARATOR

Drug: Vehicle Gel

Interventions

CD07805/47 Gel DRUG

CD07805/47 Gel 0.5% QD

CD07805/47 Gel 0.5% QD

Vehicle Gel DRUG

Vehicle Gel QD

Vehicle Gel QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, who is at least 18 years of age or older.
• A clinical diagnosis of rosacea.
• A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
• A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
• A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

You may not qualify if:

• Three (3) or more facial inflammatory lesions.
• Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
• Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
• Intraocular pressure (IOP) measurement less than 10 mm Hg.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (20)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

University of California at San Francisco

San Francisco, California, 94143-0660, United States

Location

Meda Phase, Inc

Newnan, Georgia, 30263, United States

Location

Dermatology Specialists PC

Louisville, Kentucky, 40202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Central Dermatology, PC

St Louis, Missouri, 63117, United States

Location

Skin Specialty Group

New York, New York, 10021, United States

Location

Dermatology Laser & Vein Specialists

Charlotte, North Carolina, 28207, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Oregon Dermatology & Research Center

Portland, Oregon, 97210, United States

Location

Oregon Medical Research

Portland, Oregon, 97223, United States

Location

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

DermDox

Hazleton, Pennsylvania, 18201, United States

Location

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, 29007, United States

Location

The Skin Wellness Center

Knoxville, Tennessee, 37902, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Dermatology Treatment & Research Center

Dallas, Texas, 75230, United States

Location

The Education & Research Foundation

Lynchburg, Virginia, 24501, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Madison Skin & Research

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Michael Graeber, MD
• Organization: Galderma

michael.graeber@galderma.com

609-860-8201

Study Officials

• Michael Graeber, MD

  Galderma R&D, Inc

  STUDY DIRECTOR

• William Abramovits, MD

  Dermatology Treatment & Research Center

  PRINCIPAL INVESTIGATOR

• Fran Cook-Bolden, MD

  Skin Specialty Group

  PRINCIPAL INVESTIGATOR

• Zoe Draelos, MD

  Dermatology Consulting Services, High Point NC

  PRINCIPAL INVESTIGATOR

• Joseph Fowler, MD

  Dermatology Specialists, PSC

  PRINCIPAL INVESTIGATOR

• Kimberly Grande, MD

  The Skin Wellness Center

  PRINCIPAL INVESTIGATOR

• Michael Heffernan, MD

  Central Dermatology PC

  PRINCIPAL INVESTIGATOR

• Steven Kempers, MD

  Minnesota Clinical Study Center

  PRINCIPAL INVESTIGATOR

• Mark Ling, MD

  Meda Phase, Inc.

  PRINCIPAL INVESTIGATOR

• Robert Matheson, MD

  Oregon Medical Research

  PRINCIPAL INVESTIGATOR

• Kappa Meadows, MD

  The Education & Research Foundation

  PRINCIPAL INVESTIGATOR

• Angela Moore, MD

  Arlington Center for Dermatology

  PRINCIPAL INVESTIGATOR

• Girish Munavalli, MD

  Dermatology, Laser & Vein Specialists of the Carolinas

  PRINCIPAL INVESTIGATOR

• Andrew Pollack, MD

  Philadelphia Institute of Dermatology

  PRINCIPAL INVESTIGATOR

• Phoebe Rich, MD

  Oregon Dermatology & Research Center

  PRINCIPAL INVESTIGATOR

• Harry Sharta, MD

  Madison Skin & Research

  PRINCIPAL INVESTIGATOR

• Martin Steinhoff, MD

  University of California at San Francisco

  PRINCIPAL INVESTIGATOR

• Dow Stough, MD

  Burke Pharmaceutical Research

  PRINCIPAL INVESTIGATOR

• William Werschler, MD

  Premier Clinical Research

  PRINCIPAL INVESTIGATOR

• Patricia Westmoreland, MD

  Palmetto Clinical Trial Services, LLC

  PRINCIPAL INVESTIGATOR

• Stephen Schleicher, MD

  DermDox

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 3, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 26, 2021
• Results First Posted: March 11, 2014

Record last verified: 2014-01

Locations

US (20)