drugset / Trial / NCT05259137

Intra-lesional ACE Inhibitor for Treatment of Hypertrophic Scars

NCT05259137

Phase 2/3 Withdrawn Nova Scotia Health Authority
RandomizedParallel-groupTriple-blindTreatment

Summary

Hypertrophic scarring is a difficult and debilitating condition where one develops excessive scarring after full thickness injury to the skin. This is very common in full thickness burn injury. Currently, there is no reliable treatment of these scars. One of the more effective treatments available is serial intralesional injection of a steroid. 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. In this study, the investigators will conduct a randomized control trial with a paired split-scar design. One arm receiving the standard therapy of serial intra-lesional injections of triamcinolone acetonide (TAC) and the second arm receiving an ACE-inhibitor. The outcome will be measured using the Patient and Observer Scar Assessment Scale (POSAS), a validated assessment tool.

Timeline

Start
2024-08
Primary completion
2026-08
Completion
2026-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject ENALAPRILAT ANHYDROUS Small molecule 1.25 mg/ml Other