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

RXi Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Keloid

Treatments: Drug: Placebo; Drug: RXI-109

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079168

RXI-109-1401

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.

Treatment:

Drug: Placebo

Drug: RXI-109

Cohort 2

Experimental group

Description:

Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.

Treatment:

Drug: Placebo

Drug: RXI-109