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

NCT ID: NCT01494922

Last Updated: 2021-08-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-08

Study Completion Date

2013-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Reduction in Severity of Skin Scarring

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label

Group Type EXPERIMENTAL

EXC 001 (currently called PF-06473871)

Intervention Type DRUG

Single dose administered by injection at four different times

Interventions

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EXC 001 (currently called PF-06473871)

Single dose administered by injection at four different times

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Altus Research

Lake Worth, Florida, United States

Site Status

Northwestern University,Division of Plastic Surgery

Chicago, Illinois, United States

Site Status

Jewell Plastic Surgery Center

Eugene, Oregon, United States

Site Status

Connall Consmetic Surgery

Tualatin, Oregon, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B5301003

Identifier Type: OTHER

Identifier Source: secondary_id

EXC 001-206

Identifier Type: -

Identifier Source: org_study_id

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