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

Phase 2

Completed

• Conditions: Rosacea
• Interventions: Drug: CD07805/47 Gel; Drug: Vehicle Gel

• Registration Number: NCT01174030
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-30
• Study Start: 2010-08
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Disposition First Submitted: 2011-06-06
• Disposition First Submitted QC: 2011-06-06
• Disposition First Posted: 2011-06-16
• Results First Submitted: 2013-09-19
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-24
• Results First Posted: 2014-03-11
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD07805/47 Gel 0.5% QD	CD07805/47 Gel	-
CD07805/47 Gel 0.18% QD	CD07805/47 Gel	-
CD07805/47 Gel 0.18% BID	CD07805/47 Gel	-
Vehicle Gel QD	Vehicle Gel	-
Vehicle Gel BID	Vehicle Gel	-

Primary Outcome Measures

Name	Time	Method
Composite Success	Day 29	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.

Secondary Outcome Measures

Name	Time	Method
CEA Success	Day 29	CEA success defined as 2-grade improvement on CEA.; Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.; Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema; 1. / Amost clear; slight redness; 2. / Mild erythema; definite redness; 3. / Moderate erythema; marked redness; 4. / Severe erythema; fiery redness
PSA-5 Success	day 29	Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.; PSA-5 success defined as 2-grade improvement on PSA-5.; Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness; 1. / Very mild redness; 2. / Mild redness; 3. / Moderate redness; 4. / Severe redness

Trial Locations

Locations (20)

Skin Specialty Group; 🇺🇸 New York, New York, United States

Central Dermatology, PC; 🇺🇸 Saint Louis, Missouri, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arkansas, United States

Meda Phase, Inc; 🇺🇸 Newnan, Georgia, United States

Dermatology Specialists PC; 🇺🇸 Louisville, Kentucky, United States

Dermatology Laser & Vein Specialists; 🇺🇸 Charlotte, North Carolina, United States

Dermatology Consulting Services; 🇺🇸 High Point, North Carolina, United States

Oregon Medical Research; 🇺🇸 Portland, Oregon, United States

Oregon Dermatology & Research Center; 🇺🇸 Portland, Oregon, United States

Philadelphia Institute of Dermatology; 🇺🇸 Fort Washington, Pennsylvania, United States

DermDox; 🇺🇸 Hazleton, Pennsylvania, United States

Palmetto Clinical Trial Services, LLC; 🇺🇸 Greenville, South Carolina, United States

Arlington Center for Dermatology; 🇺🇸 Arlington, Texas, United States

The Skin Wellness Center; 🇺🇸 Knoxville, Tennessee, United States

Dermatology Treatment & Research Center; 🇺🇸 Dallas, Texas, United States

The Education & Research Foundation; 🇺🇸 Lynchburg, Virginia, United States

Madison Skin & Research; 🇺🇸 Madison, Wisconsin, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States