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

NCT01640912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-09-17

No results posted yet for this study

Summary

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.

Conditions

  • Cicatrix
  • Scar Prevention

Interventions

DRUG

RXI-109

Single intradermal injection of RXI-109 at incision sites

DRUG

Placebo

Single intradermal injection of placebo at incision sites

Sponsors & Collaborators

  • RXi Pharmaceuticals, Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640912 on ClinicalTrials.gov