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

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NCT01730339

Last updated on February 21, 2020
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Study Location
University of California Irvine - Dermatology Research
Irvine, California, 92697 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Reduction of Hypertrophic Skin Scarring
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have hypertrophic (raised) breast scars from previous surgery

- Subjects must be healthy

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or
breast-feeding.

- Presence of history of breast cancer

NCT01730339
Pfizer
Completed
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery

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Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Reduction of Hypertrophic Skin Scarring
Intervention  ICMJE
  • Drug: PF-06473871
    Single dose administered by injection four different times
  • Drug: PF-06473871
    Single dose administered by injection three different times
Study Arms  ICMJE
  • Active Comparator: Group 1
    Intervention: Drug: PF-06473871
  • Active Comparator: Group 2
    Intervention: Drug: PF-06473871
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2015) 		103
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2012) 		100
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Hungary,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01730339
Other Study ID Numbers  ICMJE B5301001
2012-004355-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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