A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars

Hypertrophic Scar Clinical Trial

Official title:

An Open-Label, Multi-Center, Prospective, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery for Hypertrophic Scars in Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02246465
• Other study ID #: RXI-109-1402
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 16, 2014
• Last updated: February 21, 2018
• Start date: July 2014
• Est. completion date: March 2018

Study information

• Verified date: February 2018
• Source: RXi Pharmaceuticals, Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Adults, 21-55 years of age

• General good health

• Previous surgery or injury resulting in a hypertrophic scar

Exclusion Criteria:

• Scars on the face or front of neck may not be included in the trial

• Use of tobacco or nicotine-containing products

• Pregnant or lactating

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Drug:
• RXI-109

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RXi Pharmaceuticals, Corp.

Countries where clinical trial is conducted

United States,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing the recurrence of hypertrophic scar after scar revision surgery	To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales.	9 months
Secondary	Safety evaluation of RXI-109	To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar	9 months