Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

• Status: Not yet recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

Summary

Keloid is a fibroproliferative disorder of the skin that passes through the initial trauma area. Treatment of keloids is still a challenge because the efficacy of therapy varies between studies. Standard treatment using triamcinolone acetonide injection can cause various side effects. The efficacy of topical therapy for keloids varies. Angiotensin II in human skin, when it binds to the angiotensin II receptor type 1 (AT1R), will have pro-inflammatory, pro-proliferative and pro-fibrosis effects. This mechanism plays a role in the process of keloid formation. Losartan potassium is an angiotensin II type I receptor blocker (ARB), so it has the potential as an anti-keloid. The keloid structure with a thicker skin barrier and low biological membrane permeability of losartan potassium gives the basis for selecting ethosomal gel as a carrier for losartan potassium.

The objectives are to compare the efficacy of pre and post-treatment and between 5% losartan potassium loaded in ethosomal gel and 10 mg/ml triamcinolone acetonide injection based on the indicator score of The patient and observer scar assessment scale 3.0 (POSAS 3.0), degree of erythema and pigmentation, area size, thickness and density of human keloids.

This is an experimental study with a single-blind randomized-controlled trial (RCT) design with two groups of treatments.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gadjah Mada University
• Treatments: Losartan; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• keloid patients who came to the outpatient clinic of general hospital Syafira Pekanbaru during 2023-2024,

• age is greater than or equal to 18 year

• keloid scar than or equal to 25 cm2

• duration of keloids longer than or equal to 6 months

• no drug interventions or not currently on keloid medications for the last two months.

Exclusion Criteria:

• subjects who do not understand the rubric of The patient and observer scar assessment scale (POSAS) and were not willing to participate

• subjects with nodular keloids

• subjects within antihypertensive therapy, pregnancy, malignancy, history of allergies, active skin lesions or bleeding in the keloid area.

• subjects in the treatment of keloid within the last month.