Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01730339
First received: November 12, 2012
Last updated: February 2, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Reduction of Hypertrophic Skin Scarring
Drug: PF-06473871
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Physician Global Assessment (Overall Opinion POSAS) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician Scar Assessment (Complete POSAS) [ Time Frame: Wks 8, 11, 18 and 24 ] [ Designated as safety issue: No ]
  • Patient Global Assessment (Overall Opinion POSAS) [ Time Frame: Wks, 8, 11, 18, and 24 ] [ Designated as safety issue: No ]
  • Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) [ Time Frame: Wks 8 and 24 ] [ Designated as safety issue: No ]
  • Physician and Patient Photoguide Scar Assessment [ Time Frame: Wks 8, 11, 18 and 24 ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: December 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 Drug: PF-06473871
Single dose administered by injection four different times
Active Comparator: Group 2 Drug: PF-06473871
Single dose administered by injection three different times

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730339

Locations
United States, California
University of California Irvine
Irvine, California, United States, 92697
Associates for Plastic Surgery
La Jolla, California, United States, 92037
Advanced Cosmetic Surgery Clinic of Walnut Creek
Walnut Creek, California, United States, 94596
Anthony DeMeo, MD
Walnut Creek, California, United States, 94596
United States, Florida
Sanctuary Mediacal Center
Boca Raton, Florida, United States, 33431
Dermatology Research Institute
Coral Gables, Florida, United States, 33146
Altus Research
Lake Worth, Florida, United States, 33461
University of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
Kavali Plastic Surgery
Atlanta, Georgia, United States, 30328
Atlanta APC Plastic Surgery
Atlanta, Georgia, United States, 30308
Advanced Medical Resarch ,Inc
Atlanta, Georgia, United States, 30342
The Center for Plastic Surgery at MetroDerm
Atlanta, Georgia, United States, 30342
Atlanta APC Plastic Surgery
Conyers, Georgia, United States, 30012
Spivey Station Surgery Center
Jonesboro, Georgia, United States, 30236
United States, Illinois
Northwestern University,Division of Plastic Surgery
Chicago, Illinois, United States, 60611
United States, Missouri
Body Aesthetic Plastic Surgery
St. Louis, Missouri, United States, 63141
United States, North Carolina
The Hunstad Center for Cosmetic Plastic Surgery, P.A.
Huntersville, North Carolina, United States, 28078
United States, Oregon
Connall Consmetic Surgery
Tualatin, Oregon, United States, 97062
Meridian Center for Surgical Excellence, LLC
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Office of Paul M. Glat ,MD
Bala Cynwyd, Pennsylvania, United States, 19004
United States, Texas
Luxe Plastic Surgery
Sugar Land, Texas, United States, 77479
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Germany
Noahklinik,Klinik Plastische, Rekonstruktive und Asthetische Chirurgie, Handchirurgie am Roten Kreuz
Kassel, Hessen, Germany, 34121
Spain
Hospital Santa Creu I Sant Pau
Barcelona, Spain, 08025
Clinica La Luz
Madrid, Spain, 28003
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01730339     History of Changes
Other Study ID Numbers: B5301001, 2012-004355-37
Study First Received: November 12, 2012
Last Updated: February 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Skin scarring
cicatrix
breast scar
hypertrophic scar

Additional relevant MeSH terms:
Cicatrix
Cicatrix, Hypertrophic
Hypertrophy
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2015