Clinical trial NCT05893108: Ethosomal Gel Bearing Losartan 5% for Keloid Treatment
Official title: The Effect of Ethosomal Gel Bearing Losartan 5% on The Patient and Observer Scar Assessment Scale Score, Degree of Erythema and Pigmentation, Surface Area, Thickness and Pliability of Human Keloids
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Keloid
Keywords: Angiotensin II
Angiotensin II blocker
5 % Losartan Gel
10 mg/ml Triamcinolone acetonide
Keloid
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
Collaborators: name: Gadjah Mada University
First posted: 2023-06-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The patient and observer scar assessment scale score (POSAS 3.0)
timeFrame: change from baseline the POSAS score at 4,8, and 12 weeks, consecutively.
Secondary outcomes:
measure: Degree of erythema and hyperpigmentation
timeFrame: change from baseline the degree of erythema and hyperpigmentation at 4, 8 and 12 weeks, consecutively.
measure: the width of the keloid surface area (mm2)
timeFrame: change from baseline width of keloid surface area at 4, 8 and 12 weeks, consecutively.
measure: The thickness of keloid (mm)
timeFrame: change from baseline thickness of keloid at 4, 8 and 12 weeks, consecutively.
measure: The degree of pliability of keloid (durometer unit)
timeFrame: change from baseline pliability at 4, 8 and 12 weeks, consecutively.
Other outcomes:
Locations:
city: Pekanbaru
country: Indonesia
facility: Rumah Sakit Syafira
state: Riau
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.