NCT05893108

Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Yuni Eka Anggraini · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. One group will receive the topical application of 5% losartan gel, while the other will receive an injection of triamcinolone acetonide 10mg/ml. After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. To measure the subjective and objective changes that occur in the keloid before and after treatment, outcome assessors will be blinded. Measurements will be taken four times over the course of three months.

Conditions

• Keloid

Interventions

Type	Name	Description
DRUG	Ethosomal gel bearing losartan 5%	A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%
DRUG	triamcinolone acetonide 10 mg/ml	intralesional injection

Timeline

• Start date: 2024-03-30
• Primary completion: 2024-09-30
• Completion: 2024-10-30
• First posted: 2023-06-07
• Last updated: 2023-12-05

Locations

1 site across 1 country: Indonesia