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

Rosacea Clinical Trial

Official title:

A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174030
• Other study ID #: RD.06.SPR.18161
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erythema
• Rosacea

Intervention

Drug:
• CD07805/47 Gel
CD07805/47 Gel 0.5% QD
• Vehicle Gel
Vehicle Gel QD
• CD07805/47 Gel
CD07805/47 Gel 0.18% QD
• CD07805/47 Gel
CD07805/47 Gel 0.18% BID
• Vehicle Gel
Vehicle Gel BID

Locations

Country	Name	City	State
United States	Arlington Center for Dermatology	Arlington	Texas
United States	Dermatology Laser & Vein Specialists	Charlotte	North Carolina
United States	Dermatology Treatment & Research Center	Dallas	Texas
United States	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina
United States	DermDox	Hazleton	Pennsylvania
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Dermatology Specialists PC	Louisville	Kentucky
United States	The Education & Research Foundation	Lynchburg	Virginia
United States	Madison Skin & Research	Madison	Wisconsin
United States	Skin Specialty Group	New York	New York
United States	Meda Phase, Inc	Newnan	Georgia
United States	Oregon Dermatology & Research Center	Portland	Oregon
United States	Oregon Medical Research	Portland	Oregon
United States	Central Dermatology, PC	Saint Louis	Missouri
United States	University of California at San Francisco	San Francisco	California
United States	Premier Clinical Research	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CEA Success	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; / Amost clear; slight redness; / Mild erythema; definite redness; / Moderate erythema; marked redness; / Severe erythema; fiery redness	Day 29
Secondary	PSA-5 Success	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; / Very mild redness; / Mild redness; / Moderate redness; / Severe redness	day 29