Clinical trial NCT01318733: Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Keywords: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
timeFrame: Over 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: The Laser Institute for Dermatology
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc
state: Colorado
city: Longmont
country: United States
facility: Longmont Clinical PC
state: Colorado
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc
state: Georgia
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: Olathe
country: United States
facility: Compliant Clinical Research
state: Kansas
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Dermcenter PC- Somerset Skin Centre
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Stony Brook
country: United States
facility: DermResearch Center of New York, Inc
state: New York
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Hazleton
country: United States
facility: DermDox
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center, PLLC
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Medical Research
state: Tennessee
city: Kingsport
country: United States
facility: TriCities Medical Research
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center - Clinical Research Department
state: Washington
city: Madison
country: United States
facility: Madison Skin & Research, Inc.
state: Wisconsin
Study officials:
affiliation: Longmont Clinical PC
name: Scott Clark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmetto Medical Research
name: Lesly Davidson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Clinical Research Center of San Antonio
name: Steven Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wilmington Medical Research
name: Michael Donahue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Tennessee Medical Research
name: Timothy Gardner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennessee Clinical Research Center
name: Michael Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamzavi Dermatology
name: Fasahat Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Progressive Clinicial Research, PA
name: Mark Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Medical Research
name: Debra Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rivergate Dermatology Clinical Research Center, PLLC
name: Keith Loven, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cherry Creek Research, Inc.
name: Michael Maloney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arlington Center for Dermatology
name: Angela Moore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermcenter PC - Somerset Skin Centre
name: George Murakawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Metrolina Medical Research
name: Catherine Pointon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DermResearch Center of NewYork, Inc.
name: Elyse Rafal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DermDox
name: Stephen Schleicher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Specialists, PC
name: Joel Schlessinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Research Center
name: Leonard Swinyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Compliant Clinical Research
name: Amanda Tauscher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deaconess Clinic
name: Gary Waterman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gwinnett Clinical Research Center, Inc.
name: Jonathan Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wenatchee Valley Medical Center, Clinical Research Department
name: Morrissa Baskin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Clinical Study Center
name: Steven Kempers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Laser Institute for Dermatology
name: Ava Shamban, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Madison Skin & Research, Inc.
name: Harry Sharata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TriCities Medical Research
name: Russell Mader, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology, Laser & Vein Specialists of the Carolinas
name: Girish Munavalli, MD
role: PRINCIPAL_INVESTIGATOR
References: