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

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01730339
First received: November 12, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes

November 12, 2012
May 14, 2013
December 2012
December 2013   (final data collection date for primary outcome measure)
Physician Global Assessment (Overall Opinion POSAS) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01730339 on ClinicalTrials.gov Archive Site
  • Physician Scar Assessment (Complete POSAS) [ Time Frame: Wks 8, 11, 18 and 24 ] [ Designated as safety issue: No ]
  • Patient Global Assessment (Overall Opinion POSAS) [ Time Frame: Wks, 8, 11, 18, and 24 ] [ Designated as safety issue: No ]
  • Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) [ Time Frame: Wks 8 and 24 ] [ Designated as safety issue: No ]
  • Physician and Patient Photoguide Scar Assessment [ Time Frame: Wks 8, 11, 18 and 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
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 in Female Subjects

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 females.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Reduction of Hypertrophic Skin Scarring
  • Drug: PF-06473871
    Single dose administered by injection four different times
  • Drug: PF-06473871
    Single dose administered by injection three different times
  • Active Comparator: Group 1
    Intervention: Drug: PF-06473871
  • Active Comparator: Group 2
    Intervention: Drug: PF-06473871
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have hypertrohic (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
Female
18 Years to 55 Years
Yes
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States
 
NCT01730339
B5301001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP