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| Name | Class |
|---|---|
| Gadjah Mada University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Experimental | ethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids |
|
| Triamcinolone | Active Comparator | Intralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethosomal gel bearing losartan 5% | Drug | A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from baseline the POSAS score at 4,8, and 12 weeks, consecutively. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of erythema and hyperpigmentation | The colors are taken using dermoscopy and quantifiably analysed using image analysis ImageJ | change from baseline the degree of erythema and hyperpigmentation at 4, 8 and 12 weeks, consecutively. |
| the width of the keloid surface area (mm2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anggraini | Contact | (+62) 0813-6300-9995 | yuniea2001@mail.ugm.ac.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rumah Sakit Syafira | Pekanbaru | Riau | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16528552 | Background | Bock O, Schmid-Ott G, Malewski P, Mrowietz U. Quality of life of patients with keloid and hypertrophic scarring. Arch Dermatol Res. 2006 Apr;297(10):433-8. doi: 10.1007/s00403-006-0651-7. Epub 2006 Mar 10. | |
| 34169622 | Background | Elsaie ML. Update on management of keloid and hypertrophic scars: A systemic review. J Cosmet Dermatol. 2021 Sep;20(9):2729-2738. doi: 10.1111/jocd.14310. Epub 2021 Jul 3. |
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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.
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 to trial IPD can be requested by qualified researchers engaging in independent scientific research.
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Two groups received different treatment at the same time. Both outcomes were measured at the same time before and after treatment with 4 measurements.
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The treatment given to participants is not known by any of the outcome assessors.
| triamcinolone acetonide 10 mg/ml | Drug | intralesional injection |
|
|
The surface area is taken by digital photography and quantifiably analysed using image analysis ImageJ |
| 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 | 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) | change from baseline pliability at 4, 8 and 12 weeks, consecutively. |
| 8608339 | Background | Steckelings UM, Czarnetzki BM. The renin-angiotensin-system in the skin. Evidence for its presence and possible functional implications. Exp Dermatol. 1995 Dec;4(6):329-34. doi: 10.1111/j.1600-0625.1995.tb00056.x. |
| 32697884 | Background | Silva IMS, Assersen KB, Willadsen NN, Jepsen J, Artuc M, Steckelings UM. The role of the renin-angiotensin system in skin physiology and pathophysiology. Exp Dermatol. 2020 Sep;29(9):891-901. doi: 10.1111/exd.14159. |
| 30099811 | Background | Hedayatyanfard K, Ziai SA, Niazi F, Habibi I, Habibi B, Moravvej H. Losartan ointment relieves hypertrophic scars and keloid: A pilot study. Wound Repair Regen. 2018 Jul;26(4):340-343. doi: 10.1111/wrr.12648. Epub 2018 Oct 25. |
| 35614156 | Background | Khodaei B, Nasimi M, Nassireslami E, Seyedpour S, Rahmati J, Haddady Abianeh S, Motavalli Khiavi F. Efficacy of Topical Losartan in Management of Mammoplasty and Abdominoplasty Scars: A Randomized, Double-Blind Clinical Trial. Aesthetic Plast Surg. 2022 Oct;46(5):2580-2587. doi: 10.1007/s00266-022-02935-2. Epub 2022 May 25. |
| 38167064 | Derived | Anggraini YE, Trisnowati N, Martien R, Danarti R. A randomised clinical trial study assessing the efficacy of 5% losartan potassium loaded in ethosomal gel to treat human keloids: a trial protocol. Trials. 2024 Jan 2;25(1):12. doi: 10.1186/s13063-023-07880-2. |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |