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Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

NCT ID: NCT05893108

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2024-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Keloid

Keywords

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Angiotensin II Angiotensin II blocker 5 % Losartan Gel 10 mg/ml Triamcinolone acetonide Keloid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups received different treatment at the same time. Both outcomes were measured at the same time before and after treatment with 4 measurements.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The treatment given to participants is not known by any of the outcome assessors.

Study Groups

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Losartan

ethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids

Group Type EXPERIMENTAL

Ethosomal gel bearing losartan 5%

Intervention Type DRUG

A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%

Triamcinolone

Intralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid

Group Type ACTIVE_COMPARATOR

triamcinolone acetonide 10 mg/ml

Intervention Type DRUG

intralesional injection

Interventions

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Ethosomal gel bearing losartan 5%

A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%

Intervention Type DRUG

triamcinolone acetonide 10 mg/ml

intralesional injection

Intervention Type DRUG

Other Intervention Names

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TA 10 mg/ml

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gadjah Mada University

OTHER

Sponsor Role collaborator

Yuni Eka Anggraini

OTHER

Sponsor Role lead

Responsible Party

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Yuni Eka Anggraini

Candidate of Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rumah Sakit Syafira

Pekanbaru, Riau, Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Anggraini

Role: CONTACT

Phone: (+62) 0813-6300-9995

Email: [email protected]

Facility Contacts

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Yuni Eka Anggraini

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 16528552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34169622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8608339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32697884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30099811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35614156 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38167064 (View on PubMed)

Other Identifiers

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CT0012023

Identifier Type: -

Identifier Source: org_study_id