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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01730339
First received: November 12, 2012
Last updated: September 8, 2014
Last verified: September 2014
  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 ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: October 2014
Estimated 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:   Yes
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
Pfizer Investigational Site
Irvine, California, United States, 92697
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Walnut Creek, California, United States, 94596
United States, Florida
Pfizer Investigational Site
Boca Raton, Florida, United States, 33431
Pfizer Investigational Site
Coral Gables, Florida, United States, 33146
Pfizer Investigational Site
Lake Worth, Florida, United States, 33461
Pfizer Investigational Site
Tampa, Florida, United States, 33606
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Conyers, Georgia, United States, 30012
Pfizer Investigational Site
Jonesboro, Georgia, United States, 30236
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, North Carolina
Pfizer Investigational Site
Huntersville, North Carolina, United States, 28078
United States, Oregon
Pfizer Investigational Site
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Pfizer Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
United States, Texas
Pfizer Investigational Site
Sugar Land, Texas, United States, 77479
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States, 23507
Germany
Pfizer Investigational Site
Kassel, Hessen, Germany, 34121
Spain
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
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
Study First Received: November 12, 2012
Last Updated: September 8, 2014
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 October 21, 2014