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: January 19, 2016
Last verified: January 2016
  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
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 Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 8, 11, 18, 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 8, 11, 18, 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8, 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8, 11, 18, 24 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Number of Participants With Clinically Significant Vital Sign Abnormalities [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]
    Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.

  • Number of Participants With Abnormal Physical Examinations [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]
    Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.

  • Number of Participants With Electrocardiogram Findings [ Time Frame: Baseline, Week 11 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]
    Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]
    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.


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

  Show 40 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01730339     History of Changes
Other Study ID Numbers: B5301001  2012-004355-37 
Study First Received: November 12, 2012
Results First Received: October 14, 2015
Last Updated: January 19, 2016
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 May 02, 2016