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
Results First Received: October 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Reduction of Hypertrophic Skin Scarring
Intervention: Drug: PF-06473871

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 103 participants were randomized into the study. Of these, 100 participants received at least 1 dose of study drug and were included in the modified intent to treat (mITT) and safety population.

Reporting Groups
  Description
PF-06473871/Placebo (4* 5 mg/cm) Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
PF-06473871/Placebo (3* 5 mg/cm) Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.

Participant Flow:   Overall Study
    PF-06473871/Placebo (4* 5 mg/cm)     PF-06473871/Placebo (3* 5 mg/cm)  
STARTED     45     55  
COMPLETED     40     52  
NOT COMPLETED     5     3  
Withdrawal by Subject                 3                 2  
Lost to Follow-up                 1                 1  
Un-specified                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product.

Reporting Groups
  Description
PF-06473871/Placebo (4* 5 mg/cm) Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
PF-06473871/Placebo (3* 5 mg/cm) Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
Total Total of all reporting groups

Baseline Measures
    PF-06473871/Placebo (4* 5 mg/cm)     PF-06473871/Placebo (3* 5 mg/cm)     Total  
Number of Participants  
[units: participants]
  45     55     100  
Age  
[units: years]
Mean (Standard Deviation)
  38.2  (8.55)     37.6  (9.64)     37.9  (9.13)  
Gender  
[units: participants]
     
Female     44     53     97  
Male     1     2     3  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     3     0     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     27     39     66  
White     13     16     29  
More than one race     0     0     0  
Unknown or Not Reported     2     0     2  
Pre-Surgery Physician Overall Opinion POSAS Score [1]
[units: units on scale]
Mean (Standard Deviation)
  6.62  (1.545)     6.88  (1.277)     6.76  (1.404)  
Pre-Surgery Subject Global Assessment Score [2]
[units: units on scale]
Mean (Standard Deviation)
  9.00  (1.219)     8.49  (1.617)     8.72  (1.465)  
Pre-Surgery Physician Photoguide Score [3]
[units: units on scale]
Mean (Standard Deviation)
  3.97  (0.682)     3.98  (0.725)     3.98  (0.702)  
Pre-Surgery Participant Photoguide Score [4]
[units: units on scale]
Mean (Standard Deviation)
  4.24  (0.648)     4.28  (0.637)     4.26  (0.639)  
[1] 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).
[2] 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).
[3] Physician 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).
[4] 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).



  Outcome Measures
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1.  Primary:   Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)   [ Time Frame: Week 24 ]

2.  Secondary:   Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)   [ Time Frame: Week 8, 11, 18, 24 ]

3.  Secondary:   Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)   [ Time Frame: Week 8, 11, 18, 24 ]

4.  Secondary:   Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score   [ Time Frame: Week 8, 24 ]

5.  Secondary:   Physician and Participant Photoguide Scar Assessment Scale Score   [ Time Frame: Week 8, 11, 18, 24 ]

6.  Other Pre-specified:   Number of Participants With Clinically Significant Vital Sign Abnormalities   [ Time Frame: Baseline up to Week 24 ]

7.  Other Pre-specified:   Number of Participants With Abnormal Physical Examinations   [ Time Frame: Baseline up to Week 24 ]

8.  Other Pre-specified:   Number of Participants With Electrocardiogram Findings   [ Time Frame: Baseline, Week 11 ]

9.  Other Pre-specified:   Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest   [ Time Frame: Baseline up to Week 24 ]

10.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities   [ Time Frame: Baseline up to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1­800­718­1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01730339     History of Changes
Other Study ID Numbers: B5301001
2012-004355-37 ( EudraCT Number )
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