Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

Sponsor

Gadjah Mada University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05893108

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keloid	Drug: Ethosomal gel bearing losartan 5% Drug: triamcinolone acetonide 10 mg/ml	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 30, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Losartan

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

Drug: Ethosomal gel bearing losartan 5%

A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%

Active Comparator: Triamcinolone

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

Drug: triamcinolone acetonide 10 mg/ml

intralesional injection

Other Names:

TA 10 mg/ml

Outcome Measures

Primary Outcome Measures

The patient and observer scar assessment scale score (POSAS 3.0) [change from baseline the POSAS score at 4,8, and 12 weeks, consecutively.]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.