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

NCT01730339

Last updated date
Study Location
University of California Irvine - Dermatology Research
Irvine, California, 92697, United States
Contact
1-800-718-1021

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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

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Reduction of Hypertrophic Skin ScarringSafety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
NCT01730339
  1. Irvine, California
  2. La Jolla, California
  3. La Jolla, California
  4. Walnut Creek, California
  5. Walnut Creek, California
  6. Walnut Creek, California
  7. Whittier, California
  8. Whittier, California
  9. Boca Raton, Florida
  10. Coral Gables, Florida
  11. Lake Worth, Florida
  12. Miami, Florida
  13. Tampa, Florida
  14. Atlanta, Georgia
  15. Atlanta, Georgia
  16. Atlanta, Georgia
  17. Atlanta, Georgia
  18. Conyers, Georgia
  19. Jonesboro, Georgia
  20. Chicago, Illinois
  21. Chicago, Illinois
  22. Saint Louis, Missouri
  23. St. Louis, Missouri
  24. Garden City, New York
  25. Manhasset, New York
  26. New York, New York
  27. Huntersville, North Carolina
  28. Tualatin, Oregon
  29. Tualatin, Oregon
  30. Tualatin, Oregon
  31. Bala Cynwyd, Pennsylvania
  32. Rapid City, South Dakota
  33. Rapid City, South Dakota
  34. Sugar Land, Texas
  35. Sugar Land, Texas
  36. Norfolk, Virginia
  37. Kassel, Hessen
  38. Budapest,
  39. Barcelona,
  40. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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