Keloid
Conditions
Keywords
Angiotensin II, Angiotensin II blocker, 5 % Losartan Gel, 10 mg/ml Triamcinolone acetonide, Keloid
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.
Interventions
DRUGEthosomal gel bearing losartan 5%
A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%
intralesional injection
Sponsors
Gadjah Mada University
Yuni Eka Anggraini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The treatment given to participants is not known by any of the outcome assessors.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Indonesia
Contacts
Primary ContactAnggraini
Outcome results
None listed