Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-22

Study Completion Date

2010-04-09

Brief Summary

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This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

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Detailed Description

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Conditions

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Scar Prevention

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EXC 001

Group Type EXPERIMENTAL

EXC 001

Intervention Type DRUG

Multiple intradermal injections of EXC 001 and placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Multiple intradermal injections of EXC 001 and placebo

Interventions

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EXC 001

Multiple intradermal injections of EXC 001 and placebo

Intervention Type DRUG

Placebo

Multiple intradermal injections of EXC 001 and placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have previously had breast surgery resulting in unacceptable scars
* Subject has chosen to have the breast scars revised
* Subjects must not be pregnant or lactating

Exclusion Criteria

* Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or lactating
* Participation in another clinical trial within 30 days prior to the start of the study
* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes