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

Rosacea Clinical Trial

Official title:

A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318733
• Other study ID #: RD.06.SPR.18142
• Status: Completed
• Phase: Phase 3
• Start date: March 2011
• Est. completion date: July 2012

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• 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 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Erythema
• Rosacea

Intervention

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

Locations

Country	Name	City	State
United States	Arlington Center for Dermatology	Arlington	Texas
United States	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	Cherry Creek Research, Inc	Denver	Colorado
United States	Deaconess Clinic	Evansville	Indiana
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Rivergate Dermatology Clinical Research Center, PLLC	Goodlettsville	Tennessee
United States	DermDox	Hazleton	Pennsylvania
United States	East Tennessee Medical Research	Johnson City	Tennessee
United States	TriCities Medical Research	Kingsport	Tennessee
United States	Longmont Clinical PC	Longmont	Colorado
United States	Madison Skin & Research, Inc.	Madison	Wisconsin
United States	Palmetto Medical Research	Mount Pleasant	South Carolina
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Compliant Clinical Research	Olathe	Kansas
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Dermatology Research Center	Salt Lake City	Utah
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	The Laser Institute for Dermatology	Santa Monica	California
United States	Gwinnett Clinical Research Center, Inc	Snellville	Georgia
United States	DermResearch Center of New York, Inc	Stony Brook	New York
United States	Dermcenter PC- Somerset Skin Centre	Troy	Michigan
United States	Wenatchee Valley Medical Center - Clinical Research Department	Wenatchee	Washington
United States	Wilmington Medical Research	Wilmington	North Carolina
United States	Piedmont Medical Research	Winston-Salem	North Carolina

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	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; / Almost clear; slight redness; / Mild erythema; definite redness; / Moderate erythema; marked redness; / 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