Clinical trial

Intra-lesional ACE Inhibitor for Treatment of Hypertrophic Scars

Name
24816
Description
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.
Trial arms
Trial start
2024-08-01
Estimated PCD
2026-08-01
Trial end
2026-10-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Intralesional enalaprilat injection
1.0 mL of 1.25 mg/mL enalaprilat
Arms:
Intra-lesional triamcinolone acetonide + enalaprilat
Other names:
Enalaprilat
Size
30
Primary endpoint
Change in Patient and Observer Scar Assessment Scale (POSAS)
Outcomes will be measured at 0, 6-, 12-, and 52 weeks
Eligibility criteria
Inclusion Criteria: * Patients with scar tissue demonstrating features of hypertrophic scarring (e.g., raised, red tissue, contractures, extends beyond the boundary of the original wound) Exclusion Criteria: 1. scar does not demonstrate any distinguishing features of hypertrophic scar; 2. self-reported as pregnant and/or breastfeeding; 3. documented hepatic, heart, or renal dysfunction; 4. patients with known Cushing's disease or glaucoma; 5. documented history of angioedema; 6. patients with diabetes; 7. patients being treated with any anti-hypertensive medications 8. patients under 18 years of age
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-02-15

1 organization

1 product

1 indication