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: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Reduction in Severity of Skin Scarring
Drug: EXC 001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study to Provide Revision of Scars Resulting From Surgery in Prior Studies of EXC 001 (Currently Called PF-06473871)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: December 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label Drug: EXC 001
Single dose administered by injection at four different times

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494922

Locations
United States, Florida
Pfizer Investigational Site
Lake Worth, Florida, United States, 33461
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
Pfizer Investigational Site
Tualatin, Oregon, United States, 97062
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01494922     History of Changes
Other Study ID Numbers: EXC 001-206, B5301003
Study First Received: December 15, 2011
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Skin scarring
cicatrix
hypertrophic scar
hypertrophic scar prevention

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014