Ethosomal Gel Bearing Losartan 5% for Keloid Treatment
Status:
Not yet recruiting
Trial end date:
2024-08-30
Target enrollment:
Participant gender:
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.