Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

Keloid Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05893108
• Other study ID #: CT0012023
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 30, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: November 2023
• Source: Gadjah Mada University
• Contact: Anggraini
• Phone: (+62) 0813-6300-9995
• Email: yuniea2001[@]mail.ugm.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• Ethosomal gel bearing losartan 5%
A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%
• triamcinolone acetonide 10 mg/ml
intralesional injection

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Syafira	Pekanbaru	Riau

Sponsors (2)

Lead Sponsor	Collaborator
Yuni Eka Anggraini	Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	the width of the keloid surface area (mm2)	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.
Secondary	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.
Secondary	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.