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

RXi Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cicatrix; Scar Prevention

Treatments: Drug: Placebo; Drug: RXI-109

Study type: Interventional

Funder types: Industry

Identifiers

NCT01640912

RXI-109-1201

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

RXI-109

Experimental group

Treatment:

Drug: RXI-109

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo