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

RXi Pharmaceuticals, Corp.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cicatrix Scar Prevention

Interventions

RXI-109DRUG

Single intradermal injection of RXI-109 at incision sites

PlaceboDRUG

Single intradermal injection of placebo at incision sites

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

St Louis, Missouri, United States

Outcomes

Primary Outcomes

To assess the safety and tolerability of intradermal administration of RXI-109

Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities

Time frame: 12 weeks

Secondary Outcomes

To assess the effect of RXI-109 on scar formation following small surgical incisions

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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