Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109

NCT ID: NCT01640912

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-05-31

Brief Summary

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The primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.

Detailed Description

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Conditions

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Cicatrix Scar Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RXI-109

Group Type EXPERIMENTAL

RXI-109

Intervention Type DRUG

Single intradermal injection of RXI-109 at incision sites

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single intradermal injection of placebo at incision sites

Interventions

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RXI-109

Single intradermal injection of RXI-109 at incision sites

Intervention Type DRUG

Placebo

Single intradermal injection of placebo at incision sites

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject must be a female in general good health with normal screening values
* Subject must be a good surgical candidate for an elective abdominoplasty
* Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)

Exclusion Criteria

* Currently pregnant or lactating
* BMI greater than 35 at screening
* Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study
* Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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RXi Pharmaceuticals, Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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RXI-109-1201

Identifier Type: -

Identifier Source: org_study_id

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