Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-01

Study Completion Date

2010-07-07

Brief Summary

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This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. 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

Intervention Model

PARALLEL

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

Intradermal injections of EXC 001 and placebo given on various schedules.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intradermal injections of EXC 001 and placebo given on various schedules.

Interventions

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EXC 001

Intradermal injections of EXC 001 and placebo given on various schedules.

Intervention Type DRUG

Placebo

Intradermal injections of EXC 001 and placebo given on various schedules.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
* Subject has chosen to have an elective abdominoplasty
* Medically healthy with normal screening results
* Subjects must not be pregnant or lactating

Exclusion Criteria

* Subjects with existing scars or significant striae on the abdominal pannus
* Females who are currently pregnant or pregnant during the 12 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

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes