Clinical Trial: Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL




Official Title: The Effect of Ethosomal Gel Bearing Losartan 5% on The Patient and Observer Scar Assessment Scale Score, Degree of Erythema and Pigmentation, Surface Area, Thickness and Pliability of Human Keloids

Brief 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.