Clinical trial NCT01730339: Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
Official title: A Phase 2, Randomized, Double-blind, Within-subject, Placebo Controlled Study To Evaluate The Efficacy And Safety Of Pf 06473871 In Reducing Hypertrophic Skin Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reduction of Hypertrophic Skin Scarring
Keywords: Skin scarring
cicatrix
breast scar
hypertrophic scar
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects must have hypertrophic (raised) breast scars from previous surgery
* Subjects must be healthy

Exclusion Criteria:

* Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding.
* Presence of history of breast cancer

Primary outcomes:
measure: Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Week 24
Secondary outcomes:
measure: Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Week 8, 11, 18, 24
measure: Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Week 8, 11, 18, 24
measure: Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
timeFrame: Week 8, 24
measure: Physician and Participant Photoguide Scar Assessment Scale Score
timeFrame: Week 8, 11, 18, 24
Other outcomes:
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: Baseline up to Week 24
measure: Number of Participants With Abnormal Physical Examinations
timeFrame: Baseline up to Week 24
measure: Number of Participants With Electrocardiogram Findings
timeFrame: Baseline, Week 11
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest
timeFrame: Baseline up to Week 24
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
timeFrame: Baseline up to Week 24
Locations:
city: Irvine
country: United States
facility: University of California Irvine - Dermatology Research
state: California
city: La Jolla
country: United States
facility: Plastic Surgery and Laser Institute of San Diego
state: California
city: La Jolla
country: United States
facility: Scripps Memorial-Ximed Medical Center
state: California
city: Walnut Creek
country: United States
facility: Advanced Cosmetic Surgery Clinic of Walnut Creek
state: California
city: Walnut Creek
country: United States
facility: Anthony DeMeo, MD
state: California
city: Walnut Creek
country: United States
facility: Charles Hanson MD
state: California
city: Whittier
country: United States
facility: PIH Health Plastic Surgery and Aesthetic Medicine
state: California
city: Whittier
country: United States
facility: PIH health
state: California
city: Boca Raton
country: United States
facility: Sanctuary Mediacal Center
state: Florida
city: Coral Gables
country: United States
facility: Stephan Baker, MD PA
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami
country: United States
facility: Bayside Ambulatory Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta APC Plastic Surgery
state: Georgia
city: Atlanta
country: United States
facility: Kavali Plastic Surgery and Skin Renewal Center
state: Georgia
city: Atlanta
country: United States
facility: Perimeter Outpatient Surgery Center
state: Georgia
city: Atlanta
country: United States
facility: Advanced Medical Resarch ,Inc
state: Georgia
city: Conyers
country: United States
facility: Atlanta APC Plastic Surgery
state: Georgia
city: Jonesboro
country: United States
facility: Spivey Station Surgery Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Diagnostic Testing Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern University,Division of Plastic Surgery
state: Illinois
city: Saint Louis
country: United States
facility: Body Aesthetic Research Center
state: Missouri
city: St. Louis
country: United States
facility: Mercy Clinic Heart and Vascular
state: Missouri
city: Garden City
country: United States
facility: Long Island Plastic Surgical Group, P.C
state: New York
city: Manhasset
country: United States
facility: Long Island Plastic Surgical Group, P.C.
state: New York
city: New York
country: United States
facility: Laser Skin Surgery Center of NY
state: New York
city: Huntersville
country: United States
facility: The Hunstad Kortesis Center for Cosmetic Surgery
state: North Carolina
city: Tualatin
country: United States
facility: Connall Consmetic Surgery
state: Oregon
city: Tualatin
country: United States
facility: Meridian Center for Surgical Excellence, LLC
state: Oregon
city: Tualatin
country: United States
facility: Timothy P. Connall, MD PC
state: Oregon
city: Bala Cynwyd
country: United States
facility: Office of Paul M. Glat ,MD
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hill Surgical Hospital
state: South Dakota
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Sugar Land
country: United States
facility: Fort Bend Imaging
state: Texas
city: Sugar Land
country: United States
facility: Luxe Plastic Surgery
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Kassel
country: Germany
facility: Noahklinik,Klinik Plastische, Rekonstruktive und Asthetische Chirurgie, Handchirurgie am Roten Kreuz
state: Hessen
city: Budapest
country: Hungary
facility: Magyar Honvedseg-Egeszsegugyi Kozpont
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Clinica La Luz
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: