Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

Yuni Eka Anggraini

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Keloid

Treatments: Drug: Ethosomal gel bearing losartan 5%; Drug: triamcinolone acetonide 10 mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT05893108

CT0012023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Losartan

Experimental group

Description:

ethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids

Treatment:

Drug: Ethosomal gel bearing losartan 5%

Triamcinolone

Active Comparator group

Description:

Intralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid

Treatment:

Drug: triamcinolone acetonide 10 mg/ml