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: June 30, 2014
Last verified: June 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: August 2014
Estimated Primary Completion Date: August 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

  Show 26 Study Locations
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: June 30, 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
Hypertrophy
Keloid
Keratosis
Cicatrix, Hypertrophic
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 10, 2014