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

Cicatrix Clinical Trial

Official title:

A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640912
• Other study ID #: RXI-109-1201
• Status: Completed
• Phase: Phase 1
• First received: July 12, 2012
• Last updated: September 16, 2014
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: RXi Pharmaceuticals, Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix
• Scar Prevention

Intervention

Drug:
• RXI-109
Single intradermal injection of RXI-109 at incision sites
• Placebo
Single intradermal injection of placebo at incision sites

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RXi Pharmaceuticals, Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	Yes
Secondary	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.	12 weeks	Yes