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

Phase 1

Completed

• Conditions: Cicatrix; Scar Prevention
• Interventions: Drug: Placebo; Drug: RXI-109

• Registration Number: NCT01640912
• Lead Sponsor: RXi Pharmaceuticals, Corp.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-16
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
RXI-109	RXI-109	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of intradermal administration of RXI-109	12 weeks	Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities

Secondary Outcome Measures

Name	Time	Method
To assess the effect of RXI-109 on scar formation following small surgical incisions	12 weeks	Visual outcome and histology of scars will be assessed. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and assessed by a masked, independent, expert panel.