Ethosomal Gel Bearing Losartan 5% for Keloid Treatment
- Conditions
- Keloid
- Interventions
- Drug: Ethosomal gel bearing losartan 5%
- Registration Number
- NCT05893108
- Lead Sponsor
- Yuni Eka Anggraini
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 46
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Losartan Ethosomal gel bearing losartan 5% ethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids Triamcinolone triamcinolone acetonide 10 mg/ml Intralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Trial Locations
- Locations (1)
Rumah Sakit Syafira
🇮🇩Pekanbaru, Riau, Indonesia