A Phase 1/2 interventional study of Ethosomal gel bearing losartan 5% and triamcinolone acetonide 10 mg/ml in Keloid, sponsored by Yuni Eka Anggraini. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Yuni Eka Anggraini · Phase 1/2, Interventional, and Treatment
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's planned enrollment of 46 is above the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →This is the only study on the registry with Yuni Eka Anggraini as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids
Drug: Ethosomal gel bearing losartan 5%
Intralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid
Drug: triamcinolone acetonide 10 mg/ml
A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%
Drug page: Triamcinolone Acetonide
intralesional injection
Also known as: TA 10 mg/ml
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.
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in keloid treatment. Data or samples shared will be coded, with no protected health information included. Approval of the request of the dataset is prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Two years after publishing the result, the data will be provided and be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research.
Start is estimated for Mar 2024; primary completion for Sep 2024, 6 months later.
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This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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