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

Last updated on December 2, 2019

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Study Location
Pfizer Investigational Site
Lake Worth, Florida, 33461 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Reduction in Severity of Skin Scarring
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy adults who have participated in previous studies of EXC 001.

- Healthy adults who have chosen to have their scars revised.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01494922
Pfizer
Completed
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001

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Descriptive Information
Brief Title  ICMJE Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
Official Title  ICMJE A Phase 2, Open-label Study to Provide Revision of Scars Resulting From Surgery in Prior Studies of EXC 001 (Currently Called PF-06473871)
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Reduction in Severity of Skin Scarring
Intervention  ICMJE Drug: EXC 001 (currently called PF-06473871)
Single dose administered by injection at four different times
Study Arms  ICMJE Experimental: Open Label
Intervention: Drug: EXC 001 (currently called PF-06473871)
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: December 10, 2013)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2011)
20
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion DateSeptember 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
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 NCT01494922
Other Study ID Numbers  ICMJE EXC 001-206
B5301003
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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