Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

Cicatrix Clinical Trial

Official title:

A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780077
• Other study ID #: RXI-109-1202
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2013
• Last updated: December 2, 2014
• Start date: December 2012
• Est. completion date: November 2014

Study information

• Verified date: December 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 purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Males and females, 21-50 years of age

• General good health; if female not pregnant or lactating

• Phototype 3 and above based on the Fitzpatrick scale.

Exclusion Criteria:

• Pregnant or lactating

• Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study

• Type 1 or 2 diabetes mellitus

• A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator

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
Multiple intradermal injections of RXI-109 at incision sites
• Placebo
Multiple intradermal injections of placebo at incision sites

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RXi Pharmaceuticals, Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the timeline and levels of biomarkers	Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.	12 weeks	No
Primary	To assess the safety and tolerability of multiple intradermal administrations of RXI-109	Evaluate safety and tolerability of multiple administrations of RXI-109 at the site of intradermal injection. Examine and assess any and all local and systemic toxicities	12 weeks	Yes
Secondary	To assess the effect of multiple intradermal administrations of RXI-109 on scar formation	Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.	12 weeks	Yes