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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01494922
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Reduction in Severity of Skin Scarring Drug: EXC 001 (currently called PF-06473871) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : December 2011
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Open Label Drug: EXC 001 (currently called PF-06473871)
Single dose administered by injection at four different times


Outcome Measures

Primary Outcome Measures :
  1. Assess the safety of EXC 001 in subjects undergoing elective revision of scars from prior surgery [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Physician Scar Assessment Scale [ Time Frame: Wk 24 ]
  2. Subject Scar Assessment Scale [ Time Frame: Wk 24 ]
  3. Physician Reported Scar Severity Scale (Photonumeric Guide) [ Time Frame: Wk 24 ]
  4. Subject Reported Scar Severity Scale (Photonumeric Guide) [ Time Frame: Wk 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01494922     History of Changes
Other Study ID Numbers: EXC 001-206
B5301003
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: December 2013

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

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes