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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%
intralesional injection
Rumah Sakit Syafira
Pekanbaru, Riau, Indonesia
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.
Time frame: change from baseline the POSAS score at 4,8, and 12 weeks, consecutively.
Degree of erythema and hyperpigmentation
The colors are taken using dermoscopy and quantifiably analysed using image analysis ImageJ
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: change from baseline pliability at 4, 8 and 12 weeks, consecutively.
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