Intra-lesional ACE Inhibitor for Treatment of Keloid Scars

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Keloid scarring is a difficult and debilitating condition where one develops excessive scarring after incision or laceration to the skin. Currently, there is no reliable treatment of these scars. One of the more effective treatments available is serial intralesional injection of a steroid after 90% excision of the keloid scar.

Angiotensin II is an active peptide in the body that results in vasoconstriction of the blood vessels when activated. Medications used today like angiotensin II receptor blocks and angiotensin converting enzyme inhibitors work to prevent the activation of angiotensin II and are mainly used to help control blood pressure. Previous studies in rat models have shown that angiotensin II receptor blockers can effectively reduce scar hypertrophy (a hallmark of keloid scarring).

In this study, the investigators will conduct a randomized control trial, with one arm receiving the standard therapy of 90% excision of the keloid scar with serial intra-lesional injections of triamcinolone injection and the second arm receiving a combination of triamcinolone + ACE-inhibitor. The outcome will be measured using the Patient and Observer Scar Assessment Scale (POSAS), a validated assessment tool.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nova Scotia Health Authority
• Treatments: Enalapril; Enalaprilat

Criteria

Inclusion Criteria:

• Patients with scar tissue demonstrating features of keloid scarring (e.g., raised, red tissue, contractures, extends beyond the boundary of the original wound)

Exclusion Criteria:

• Scar does not demonstrate any distinguishing features of keloidal scar

• Self-reported as pregnant and/or breastfeeding

• Documented hepatic, heart or renal dysfunction

• Patients with known Cushing's disease or glaucoma

• Patients who have had previous attempts at treatment of the keloid scar