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Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

NCT ID: NCT01780077

Last Updated: 2014-12-03

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

2012-12-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.

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

Multiple intradermal injections of RXI-109 at incision sites

Placebo

Intervention Type DRUG

Multiple intradermal injections of placebo at incision sites

Placebo

Group Type PLACEBO_COMPARATOR

RXI-109

Intervention Type DRUG

Multiple intradermal injections of RXI-109 at incision sites

Placebo

Intervention Type DRUG

Multiple intradermal injections of placebo at incision sites

Interventions

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RXI-109

Multiple intradermal injections of RXI-109 at incision sites

Intervention Type DRUG

Placebo

Multiple intradermal injections of placebo at incision sites

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females, 21-50 years of age
* General good health; if female not pregnant or lactating
* Phototype 3 and above based on the Fitzpatrick scale.

Exclusion Criteria

* Pregnant or lactating
* Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study
* Type 1 or 2 diabetes mellitus
* A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

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

Other Identifiers

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RXI-109-1202

Identifier Type: -

Identifier Source: org_study_id