A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults

Hypertrophic Scar Clinical Trial

Official title:

A Multi-Center, Prospective, Randomized, Double-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery on Transverse Hypertrophic Scars on the Lower Abdomen Resulting From Previous Surgeries in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030275
• Other study ID #: RXI-109-1301
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2014
• Last updated: June 20, 2016
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: RXi Pharmaceuticals, Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 abdominal scar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Adults, 21-55 years of age in general good health

• Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting in a transverse hypertrophic scar of = 11 cm in length

• Scar to be revised must have been present for > 9 months

Exclusion Criteria:

• Use of tobacco or nicotine-containing products

• Pregnant or lactating

• Post-menopausal or full hysterectomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Drug:
• RXI-109
surgery.
• Placebo
surgery.

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	Reduction in recurrence of hypertrophic scarring after scar revision surgery	To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a hypertrophic abdominal scar	9 months	No
Secondary	Safety 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 abdominal scar	9 months	Yes