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

NCT01355471 | Completed Phase 3 Results

• 1 other identifier: RD.06.SPR.18141
• Study Type: interventional
• Target: 293
• Locations: 2 countries
• Sites: 15

Brief 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

Keywords

rosacea

Outcome Measures

Primary Outcomes (1)

• Composite Success

  Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

  Day 29

Study Arms (2)

CD07805/47 gel

EXPERIMENTAL

Drug: CD07805/47 Gel

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CD07805/47 Gel DRUG

applied topically once daily

CD07805/47 gel

Placebo DRUG

applied topically once daily

Placebo

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 greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
• A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the 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.
• Presence of three (3) or more facial inflammatory lesions of rosacea.
• Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
• Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (15)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Baumann Cosmetic and Research Institute

Miami Beach, Florida, 33140, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40202, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Central Dermatology PC

St Louis, Missouri, 63117, United States

Location

Skin Specialty Dermatology

New York, New York, 10155, United States

Location

Haber Dermatology & Cosmetic Surgery

South Euclid, Ohio, 44118, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, 29607, United States

Location

J&S Studies Inc.

College Station, Texas, 77845, United States

Location

Premier Clinical Research

Spokane, Washington, 99201, United States

Location

Kirk Barber Research Inc.

Calgary, Alberta, T25 3B3, Canada

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Newlab Clinical Research Inc.

St. John's, Newfoundland and Labrador, A1C2H5, Canada

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

  STUDY CHAIR

• Kirk Barber, MD

  Kirk Barber Research Inc.

  PRINCIPAL INVESTIGATOR

• Leslie Baumann, MD

  Baumann Cosmetic and Research Institute

  PRINCIPAL INVESTIGATOR

• Fran Cook-Bolden, MD

  Skin Specialty Dermatology

  PRINCIPAL INVESTIGATOR

• Joseph Fowler, MD

  Dermatology Specialists PSC

  PRINCIPAL INVESTIGATOR

• Steven Grekin, DO

  Grekin Skin Institute

  PRINCIPAL INVESTIGATOR

• Wayne Gulliver, MD

  Newlab Clinical Research Inc.

  PRINCIPAL INVESTIGATOR

• Robert Haber, MD

  Haber Dermatology & Cosmetic Surgery

  PRINCIPAL INVESTIGATOR

• Michael Heffernan, MD

  Central Dermatology

  PRINCIPAL INVESTIGATOR

• Terry Jones, MD

  J&S Studies Inc.

  PRINCIPAL INVESTIGATOR

• Ian Landells, MD

  Nexus Clinical Research

  PRINCIPAL INVESTIGATOR

• Mark Ling, MD

  MedaPhase, Inc.

  PRINCIPAL INVESTIGATOR

• Phoebe Rich, MD

  Oregon Dermatology and Research Center

  PRINCIPAL INVESTIGATOR

• Dow Stough, MD

  Burke Pharmaceutical Research

  PRINCIPAL INVESTIGATOR

• William Werschler, MD

  Premier Clinical Research

  PRINCIPAL INVESTIGATOR

• Patricia Westmoreland, MD

  Palmetto Clinical Trials Services, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 18, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 18, 2021
• Results First Posted: November 21, 2013

Record last verified: 2013-09

Locations

CA (3); US (12)