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

NCT01318733 | Completed Phase 3 Results

• 1 other identifier: RD.06.SPR.18142
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 27

Brief Summary

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Conditions

Rosacea

Keywords

Rosacea

Outcome Measures

Primary Outcomes (1)

• Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.

  Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Almost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.

  Over 1 year

Study Arms (1)

CD07805/47 Gel 0.5%

EXPERIMENTAL

Drug: CD07805/47 gel 0.5%

Interventions

CD07805/47 gel 0.5% DRUG

In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.

CD07805/47 Gel 0.5%

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 facial rosacea.
• A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
• A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

You may not qualify if:

• Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
• 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.
• Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
• Current treatment with monoamine oxidase (MAO) inhibitors.
• Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
• Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (27)

The Laser Institute for Dermatology

Santa Monica, California, 90404, United States

Location

Cherry Creek Research, Inc

Denver, Colorado, 80209, United States

Location

Longmont Clinical PC

Longmont, Colorado, 80501, United States

Location

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, 30078, United States

Location

Deaconess Clinic

Evansville, Indiana, 47713, United States

Location

Compliant Clinical Research

Olathe, Kansas, 66061, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Dermcenter PC- Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

DermResearch Center of New York, Inc

Stony Brook, New York, 11790, United States

Location

Metrolina Medical Research

Charlotte, North Carolina, 27277, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Wilmington Medical Research

Wilmington, North Carolina, 28401, United States

Location

Piedmont Medical Research

Winston-Salem, North Carolina, 27103, United States

Location

DermDox

Hazleton, Pennsylvania, 18201, United States

Location

Palmetto Medical Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Rivergate Dermatology Clinical Research Center, PLLC

Goodlettsville, Tennessee, 37072, United States

Location

East Tennessee Medical Research

Johnson City, Tennessee, 37604, United States

Location

TriCities Medical Research

Kingsport, Tennessee, 37660, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78229, United States

Location

Dermatology Research Center

Salt Lake City, Utah, 84124, United States

Location

Wenatchee Valley Medical Center - Clinical Research Department

Wenatchee, Washington, 98801, United States

Location

Madison Skin & Research, Inc.

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

• Scott Clark, MD

  Longmont Clinical PC

  PRINCIPAL INVESTIGATOR

• Lesly Davidson, MD

  Palmetto Medical Research

  PRINCIPAL INVESTIGATOR

• Steven Davis, MD

  Dermatology Clinical Research Center of San Antonio

  PRINCIPAL INVESTIGATOR

• Michael Donahue, MD

  Wilmington Medical Research

  PRINCIPAL INVESTIGATOR

• Timothy Gardner, MD

  East Tennessee Medical Research

  PRINCIPAL INVESTIGATOR

• Michael Gold, MD

  Tennessee Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Fasahat Hamzavi, MD

  Hamzavi Dermatology

  PRINCIPAL INVESTIGATOR

• Mark Lee, MD

  Progressive Clinicial Research, PA

  PRINCIPAL INVESTIGATOR

• Debra Liu, MD

  Piedmont Medical Research

  PRINCIPAL INVESTIGATOR

• Keith Loven, MD

  Rivergate Dermatology Clinical Research Center, PLLC

  PRINCIPAL INVESTIGATOR

• Michael Maloney, MD

  Cherry Creek Research, Inc.

  PRINCIPAL INVESTIGATOR

• Angela Moore, MD

  Arlington Center for Dermatology

  PRINCIPAL INVESTIGATOR

• George Murakawa, MD

  Dermcenter PC - Somerset Skin Centre

  PRINCIPAL INVESTIGATOR

• Catherine Pointon, MD

  Metrolina Medical Research

  PRINCIPAL INVESTIGATOR

• Elyse Rafal, MD

  DermResearch Center of NewYork, Inc.

  PRINCIPAL INVESTIGATOR

• Stephen Schleicher, MD

  DermDox

  PRINCIPAL INVESTIGATOR

• Joel Schlessinger, MD

  Skin Specialists, PC

  PRINCIPAL INVESTIGATOR

• Leonard Swinyer, MD

  Dermatology Research Center

  PRINCIPAL INVESTIGATOR

• Amanda Tauscher, MD

  Compliant Clinical Research

  PRINCIPAL INVESTIGATOR

• Gary Waterman, MD

  Deaconess Clinic

  PRINCIPAL INVESTIGATOR

• Jonathan Weiss, MD

  Gwinnett Clinical Research Center, Inc.

  PRINCIPAL INVESTIGATOR

• Morrissa Baskin, MD

  Wenatchee Valley Medical Center, Clinical Research Department

  PRINCIPAL INVESTIGATOR

• Steven Kempers, MD

  Minnesota Clinical Study Center

  PRINCIPAL INVESTIGATOR

• Ava Shamban, MD

  The Laser Institute for Dermatology

  PRINCIPAL INVESTIGATOR

• Harry Sharata, MD

  Madison Skin & Research, Inc.

  PRINCIPAL INVESTIGATOR

• Russell Mader, MD

  TriCities Medical Research

  PRINCIPAL INVESTIGATOR

• Girish Munavalli, MD

  Dermatology, Laser & Vein Specialists of the Carolinas

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 18, 2021
• Results First Posted: January 8, 2014

Record last verified: 2014-03

Locations

US (27)