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Trial record 1 of 1 for:    NCT01037413
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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

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ClinicalTrials.gov Identifier: NCT01037413
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 21, 2009
First Posted Date  ICMJE December 23, 2009
Last Update Posted Date October 11, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
To assess the efficacy of EXC 001 in reducing skin scarring in subjects undergoing an elective revision of scars resulting from prior breast surgery. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
To assess the efficacy of EXC 001 in reducing skin scarring in subjects undergoing an elective revision of scars resulting from prior breast surgery.
Change History Complete list of historical versions of study NCT01037413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
To assess the safety of EXC 001 in subjects undergoing an elective revision of scars resulting from prior breast surgery. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
To assess the safety of EXC 001 in subjects undergoing an elective revision of scars resulting from prior breast surgery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Within-subject Controlled Study to Evaluate Efficacy and Safety of EXC 001 for the Amelioration of Scarring Following Revision of Scars Resulting From Prior Breast Surgery in Adult Female Subjects
Brief Summary The study will investigate the ability of EXC 001 to improve the appearance of scars in subjects undergoing revision of scars resulting from prior breast surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Scar Prevention
Intervention  ICMJE
  • Drug: EXC 001
    Multiple intradermal injections of EXC 001 and placebo
  • Drug: Placebo
    Multiple intradermal injections of EXC 001 and placebo
Study Arms  ICMJE
  • Experimental: EXC 001
    Intervention: Drug: EXC 001
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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: March 1, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2009)
40
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have previously had breast surgery resulting in unacceptable scars
  • Subject has chosen to have the breast scars revised
  • Subjects must not be pregnant or lactating

Exclusion Criteria:

  • Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or lactating
  • Participation in another clinical trial within 30 days prior to the start of the study
  • Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01037413
Other Study ID Numbers  ICMJE EXC 001-203
Has Data Monitoring Committee Yes
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 Not Provided
PRS Account Pfizer
Verification Date October 2012

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