A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

Keloid Clinical Trial

Official title:

A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079168
• Other study ID #: RXI-109-1401
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2014
• Last updated: June 13, 2016
• Start date: March 2014
• Est. completion date: March 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

To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2016
• Est. primary completion date: March 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.

• Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso.

• Keloids to be excised must have been present for > 1 year.

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: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• RXI-109

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RXi Pharmaceuticals, Corp.

Countries where clinical trial is conducted

United States,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the recurrence of a keloid after keloid excision	To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision	6 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 excision of a keloid	6 months	No