search
Back to results

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

Primary Purpose

Reduction of Hypertrophic Skin Scarring

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06473871
PF-06473871
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reduction of Hypertrophic Skin Scarring focused on measuring Skin scarring, cicatrix, breast scar, hypertrophic scar

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Irvine - Dermatology Research
  • Plastic Surgery and Laser Institute of San Diego
  • Scripps Memorial-Ximed Medical Center
  • Advanced Cosmetic Surgery Clinic of Walnut Creek
  • Anthony DeMeo, MD
  • Charles Hanson MD
  • PIH Health Plastic Surgery and Aesthetic Medicine
  • PIH health
  • Sanctuary Mediacal Center
  • Stephan Baker, MD PA
  • Altus Research
  • Bayside Ambulatory Center
  • University of South Florida
  • Atlanta APC Plastic Surgery
  • Kavali Plastic Surgery and Skin Renewal Center
  • Perimeter Outpatient Surgery Center
  • Advanced Medical Resarch ,Inc
  • Atlanta APC Plastic Surgery
  • Spivey Station Surgery Center
  • Northwestern University Diagnostic Testing Center
  • Northwestern University,Division of Plastic Surgery
  • Body Aesthetic Research Center
  • Mercy Clinic Heart and Vascular
  • Long Island Plastic Surgical Group, P.C
  • Long Island Plastic Surgical Group, P.C.
  • Laser Skin Surgery Center of NY
  • The Hunstad Kortesis Center for Cosmetic Surgery
  • Connall Consmetic Surgery
  • Meridian Center for Surgical Excellence, LLC
  • Timothy P. Connall, MD PC
  • Office of Paul M. Glat ,MD
  • Black Hill Surgical Hospital
  • Health Concepts
  • Fort Bend Imaging
  • Luxe Plastic Surgery
  • Virginia Clinical Research, Inc.
  • Noahklinik,Klinik Plastische, Rekonstruktive und Asthetische Chirurgie, Handchirurgie am Roten Kreuz
  • Magyar Honvedseg-Egeszsegugyi Kozpont
  • Hospital Santa Creu I Sant Pau
  • Clinica La Luz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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.

Full Information

First Posted
November 12, 2012
Last Updated
January 19, 2016
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01730339
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction of Hypertrophic Skin Scarring
Keywords
Skin scarring, cicatrix, breast scar, hypertrophic scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PF-06473871
Intervention Description
Single dose administered by injection four different times
Intervention Type
Drug
Intervention Name(s)
PF-06473871
Intervention Description
Single dose administered by injection three different times
Primary Outcome Measure Information:
Title
Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Description
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.
Time Frame
Week 8, 11, 18, 24
Title
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Description
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
Time Frame
Week 8, 11, 18, 24
Title
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
Description
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.
Time Frame
Week 8, 24
Title
Physician and Participant Photoguide Scar Assessment Scale Score
Description
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.
Time Frame
Week 8, 11, 18, 24
Other Pre-specified Outcome Measures:
Title
Number of Participants With Clinically Significant Vital Sign Abnormalities
Description
Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Abnormal Physical Examinations
Description
Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Electrocardiogram Findings
Description
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.
Time Frame
Baseline, Week 11
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest
Description
Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
Description
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.
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of California Irvine - Dermatology Research
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Plastic Surgery and Laser Institute of San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scripps Memorial-Ximed Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Advanced Cosmetic Surgery Clinic of Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Anthony DeMeo, MD
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Charles Hanson MD
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
PIH Health Plastic Surgery and Aesthetic Medicine
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
PIH health
City
Whittier
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Sanctuary Mediacal Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Stephan Baker, MD PA
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Bayside Ambulatory Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Atlanta APC Plastic Surgery
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Kavali Plastic Surgery and Skin Renewal Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Perimeter Outpatient Surgery Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Advanced Medical Resarch ,Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta APC Plastic Surgery
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30012
Country
United States
Facility Name
Spivey Station Surgery Center
City
Jonesboro
State/Province
Georgia
ZIP/Postal Code
30236
Country
United States
Facility Name
Northwestern University Diagnostic Testing Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern University,Division of Plastic Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Body Aesthetic Research Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Clinic Heart and Vascular
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Long Island Plastic Surgical Group, P.C
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Long Island Plastic Surgical Group, P.C.
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Laser Skin Surgery Center of NY
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Hunstad Kortesis Center for Cosmetic Surgery
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Connall Consmetic Surgery
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Meridian Center for Surgical Excellence, LLC
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Timothy P. Connall, MD PC
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Office of Paul M. Glat ,MD
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Black Hill Surgical Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Fort Bend Imaging
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Luxe Plastic Surgery
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Noahklinik,Klinik Plastische, Rekonstruktive und Asthetische Chirurgie, Handchirurgie am Roten Kreuz
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34121
Country
Germany
Facility Name
Magyar Honvedseg-Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Clinica La Luz
City
Madrid
ZIP/Postal Code
28003
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5301001&StudyName=Safety%20and%20Efficacy%20Study%20of%20PF-06473871%20to%20Reduce%20Hypertrophic%20Scars%20from%20Recurring%20Post-Revision%20Surgery
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs