Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Keloid

Intervention / Treatment
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* Drug: Ethosomal gel bearing losartan 5%
* Drug: triamcinolone acetonide 10 mg/ml


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups received different treatment at the same time. Both outcomes were measured at the same time before and after treatment with 4 measurements.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan<br>ethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids | Drug: Ethosomal gel bearing losartan 5%<br>* A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%<br>|
| Active Comparator: Triamcinolone<br>Intralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid | Drug: triamcinolone acetonide 10 mg/ml<br>* intralesional injection<br>* Other names: TA 10 mg/ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient and observer scar assessment scale score (POSAS 3.0) | The Patient and Observer Scar Assessment Scale 3.0 consists of sixteen items of the patient questionnaire (PSAS) with maximum and minimum values are 80 and 16, consecutively; and seven items of the observer questionnaire (OSAS) with maximum and minimum values are 35 and 7, consecutively. The lower score, the better result of the keloid. | change from baseline the POSAS score at 4,8, and 12 weeks, consecutively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of erythema and hyperpigmentation | The colors are taken using dermoscopy and quantifiably analysed using image analysis ImageJ | change from baseline the degree of erythema and hyperpigmentation at 4, 8 and 12 weeks, consecutively. | 
| the width of the keloid surface area (mm2) | The surface area is taken by digital photography and quantifiably analysed using image analysis ImageJ | change from baseline width of keloid surface area at 4, 8 and 12 weeks, consecutively. | 
| The thickness of keloid (mm) | The thickness of the keloids is assessed using high-frequency ultrasonography | change from baseline thickness of keloid at 4, 8 and 12 weeks, consecutively. | 
| The degree of pliability of keloid (durometer unit) | The pliability of keloids is assessed using durometer shore type oo (Teclock Japan) | change from baseline pliability at 4, 8 and 12 weeks, consecutively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiotensin II, Angiotensin II blocker, 5 % Losartan Gel, 10 mg/ml Triamcinolone acetonide, Keloid