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

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

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.

Study Overview

• Status: Completed
• Conditions: Reduction of Hypertrophic Skin Scarring
• Intervention / Treatment: Drug: PF-06473871; Drug: PF-06473871

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Kassel, Hessen, Germany, 34121
      • Noahklinik,Klinik Plastische, Rekonstruktive und Asthetische Chirurgie, Handchirurgie am Roten Kreuz
• Hungary
  • Budapest, Hungary, 1134
    • Magyar Honvédség-Egészségügyi Központ
• Spain
  • Barcelona, Spain, 08025
    • Hospital Santa Creu i Sant Pau
  • Madrid, Spain, 28003
    • Clinica La Luz
• United States
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine - Dermatology Research
    • La Jolla, California, United States, 92037
      • Plastic Surgery and Laser Institute of San Diego
    • La Jolla, California, United States, 92037
      • Scripps Memorial-Ximed Medical Center
    • Walnut Creek, California, United States, 94596
      • Advanced Cosmetic Surgery Clinic of Walnut Creek
    • Walnut Creek, California, United States, 94596
      • Anthony DeMeo, MD
    • Walnut Creek, California, United States, 94598
      • Charles Hanson MD
    • Whittier, California, United States, 90602
      • PIH Health Plastic Surgery and Aesthetic Medicine
    • Whittier, California, United States, 90640
      • PIH Health
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Sanctuary Mediacal Center
    • Coral Gables, Florida, United States, 33146
      • Stephan Baker, MD PA
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Miami, Florida, United States, 33133
      • Bayside Ambulatory Center
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta APC Plastic Surgery
    • Atlanta, Georgia, United States, 30328
      • Kavali Plastic Surgery and Skin Renewal Center
    • Atlanta, Georgia, United States, 30328
      • Perimeter Outpatient Surgery Center
    • Atlanta, Georgia, United States, 30342
      • Advanced Medical Resarch ,Inc
    • Conyers, Georgia, United States, 30012
      • Atlanta APC Plastic Surgery
    • Jonesboro, Georgia, United States, 30236
      • Spivey Station Surgery Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Diagnostic Testing Center
    • Chicago, Illinois, United States, 60611
      • Northwestern University,Division of Plastic Surgery
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Body Aesthetic Research Center
    • St. Louis, Missouri, United States, 63141
      • Mercy Clinic Heart and Vascular
  • New York
    • Garden City, New York, United States, 11530
      • Long Island Plastic Surgical Group, P.C
    • Manhasset, New York, United States, 11030
      • Long Island Plastic Surgical Group, P.C.
    • New York, New York, United States, 10016
      • Laser Skin Surgery Center of NY
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • The Hunstad Kortesis Center for Cosmetic Surgery
  • Oregon
    • Tualatin, Oregon, United States, 97062
      • Connall Consmetic Surgery
    • Tualatin, Oregon, United States, 97062
      • Meridian Center for Surgical Excellence, LLC
    • Tualatin, Oregon, United States, 97062
      • Timothy P. Connall, MD PC
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States, 19004
      • Office of Paul M. Glat ,MD
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
    • Rapid City, South Dakota, United States, 57702
      • Black Hill Surgical Hospital
  • Texas
    • Sugar Land, Texas, United States, 77478
      • Fort Bend Imaging
    • Sugar Land, Texas, United States, 77479
      • Luxe Plastic Surgery
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1	Drug: PF-06473871; Single dose administered by injection four different times; Drug: PF-06473871; Single dose administered by injection three different times
Active Comparator: Group 2	Drug: PF-06473871; Single dose administered by injection four different times; Drug: PF-06473871; Single dose administered by injection three different times

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)	Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)	Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.	Week 8, 11, 18, 24
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)	Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received	Week 8, 11, 18, 24
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score	PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.	Week 8, 24
Physician and Participant Photoguide Scar Assessment Scale Score	Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.	Week 8, 11, 18, 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinically Significant Vital Sign Abnormalities	Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.	Baseline up to Week 24
Number of Participants With Abnormal Physical Examinations	Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.	Baseline up to Week 24
Number of Participants With Electrocardiogram Findings	Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator.	Baseline, Week 11
Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest	Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.	Baseline up to Week 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported.	Baseline up to Week 24

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 12, 2012
• First Submitted That Met QC Criteria: November 15, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Skin scarring; cicatrix; breast scar; hypertrophic scar
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Hypertrophy; Cicatrix
• Other Study ID Numbers: B5301001; 2012-004355-37 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No