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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01346969
First received: May 1, 2011
Last updated: May 30, 2013
Last verified: January 2013

May 1, 2011
May 30, 2013
June 2011
April 2012   (final data collection date for primary outcome measure)
Physician Scar Assessment [ Time Frame: Wks 24 ] [ Designated as safety issue: No ]
Assess the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing elective revision of scars from prior surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Efficacy will be assessed by:

  • Physician Scar Assessment at 6 months
  • Expert Panel Visual Analog Scale score at 6 months
  • Subject Scar Assessment at 6 months
Complete list of historical versions of study NCT01346969 on ClinicalTrials.gov Archive Site
  • Physician Scar Assessment [ Time Frame: Wks 11, 18 ] [ Designated as safety issue: No ]
  • Expert Panel Assessment of Blinded Photographs Uing VAS [ Time Frame: Wks 11, 18, 24 ] [ Designated as safety issue: No ]
  • Subject Scar Assessment [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
  • Scar Severity Assessment Using a Photonumeric Guide by the Physician and the Subject [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
Assess the safety of EXC 001 in subjects undergoing elective revision of scars from prior surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety will be assessed by number of participants with adverse events
Not Provided
Not Provided
 
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
A Phase 2, Randomized, Double-blind, Within-subject Controlled Study to Evaluate Efficacy and Safety of Various Doses and Regimens of EXC 001 for the Amelioration of Scarring Following Revision of Scars From Prior Breast Surgery in Adult Subjects

The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.

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 in Hypertrophic Skin Scarring
  • Drug: EXC 001
    Single-dose administered by injection four different times
  • Drug: EXC 001
    Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
  • Drug: EXC 001
    Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2
  • Drug: EXC 001
    Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
  • Active Comparator: Group 1
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 2
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 3
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 4
    Intervention: Drug: EXC 001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have previous had breast surgery resulting in unacceptable scars.
  • Subject has chosen to have breast scars revised.
  • Subject 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 the study.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01346969
EXC 001-204, B5301004
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

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