Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

NCT05893108 | Unknown Phase 1

• 1 other identifier: CT0012023
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Degree of erythema and hyperpigmentation

  change from baseline the degree of erythema and hyperpigmentation at 4, 8 and 12 weeks, consecutively.

• the width of the keloid surface area (mm2)

  change from baseline width of keloid surface area at 4, 8 and 12 weeks, consecutively.

• The thickness of keloid (mm)

  change from baseline thickness of keloid at 4, 8 and 12 weeks, consecutively.

• The degree of pliability of keloid (durometer unit)

  change from baseline pliability at 4, 8 and 12 weeks, consecutively.

Study Arms (2)

Losartan

EXPERIMENTAL

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

Drug: Ethosomal gel bearing losartan 5%

Triamcinolone

ACTIVE COMPARATOR

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

Drug: triamcinolone acetonide 10 mg/ml

Interventions

Ethosomal gel bearing losartan 5% DRUG

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

Losartan

triamcinolone acetonide 10 mg/ml DRUG

intralesional injection

Also known as: TA 10 mg/ml

Triamcinolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuni Eka Anggraini: lead
• Gadjah Mada University: collaborator

Study Sites (1)

Rumah Sakit Syafira

Pekanbaru, Riau, Indonesia

Location

Related Publications (7)

• 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.

  PMID: 16528552 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.

  PMID: 34169622 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.

  PMID: 8608339 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.

  PMID: 32697884 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.

  PMID: 30099811 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.

  PMID: 35614156 BACKGROUND

• 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.

  PMID: 38167064 DERIVED

MeSH Terms

Conditions

Keloid

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Anggraini

CONTACT

(+62) 0813-6300-9995; yuniea2001@mail.ugm.ac.id

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The treatment given to participants is not known by any of the outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Candidate of Doctor

Model Details: Two groups received different treatment at the same time. Both outcomes were measured at the same time before and after treatment with 4 measurements.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 7, 2023
• Study Start: March 30, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.

Locations

ID (1)