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Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01494922
First received: December 15, 2011
Last updated: November 6, 2014
Last verified: December 2013

December 15, 2011
November 6, 2014
December 2011
September 2013   (final data collection date for primary outcome measure)
Assess the safety of EXC 001 in subjects undergoing elective revision of scars from prior surgery [ Time Frame: Week 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.
Complete list of historical versions of study NCT01494922 on ClinicalTrials.gov Archive Site
  • Physician Scar Assessment Scale [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
  • Subject Scar Assessment Scale [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
  • Physician Reported Scar Severity Scale (Photonumeric Guide) [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
  • Subject Reported Scar Severity Scale (Photonumeric Guide) [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
Assess the efficacy of EXC 001 in subjects undergoing elective revision of scars from prior surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Physician and subject scar assessment
Not Provided
Not Provided
 
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
A Phase 2, Open-label Study to Provide Revision of Scars Resulting From Surgery in Prior Studies of EXC 001 (Currently Called PF-06473871)

The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Reduction in Severity of Skin Scarring
Drug: EXC 001 (currently called PF-06473871)
Single dose administered by injection at four different times
Experimental: Open Label
Intervention: Drug: EXC 001 (currently called PF-06473871)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy adults who have participated in previous studies of EXC 001.
  • Healthy adults who have chosen to have their scars revised.

Exclusion Criteria:

  • Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or breast feeding.
  • Participation in another clinical trial within 30 days prior to the start of the study.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01494922
EXC 001-206, B5301003
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

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