Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

November 29, 2023 updated by: Yuni Eka Anggraini

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • Riau
      • Pekanbaru, Riau, Indonesia
        • Rumah Sakit Syafira
        • Contact:
          • Yuni Eka Anggraini
        • Principal Investigator:
          • Yuni Anggriaini
        • Sub-Investigator:
          • Niken Trisnowati
        • Sub-Investigator:
          • Ronny Martien
        • Sub-Investigator:
          • Retno Danarti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Losartan
ethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids
Drug: Ethosomal gel bearing losartan 5%
A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%
Active Comparator: Triamcinolone
Intralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid
Drug: triamcinolone acetonide 10 mg/ml
intralesional injection
Other Names:
  • TA 10 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The patient and observer scar assessment scale score (POSAS 3.0)
Time Frame: change from baseline the POSAS score at 4,8, and 12 weeks, consecutively.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of erythema and hyperpigmentation
Time Frame: change from baseline the degree of erythema and hyperpigmentation at 4, 8 and 12 weeks, consecutively.
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)
Time Frame: change from baseline width of keloid surface area at 4, 8 and 12 weeks, consecutively.
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)
Time Frame: change from baseline thickness of keloid at 4, 8 and 12 weeks, consecutively.
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)
Time Frame: change from baseline pliability at 4, 8 and 12 weeks, consecutively.
The pliability of keloids is assessed using durometer shore type oo (Teclock Japan)
change from baseline pliability at 4, 8 and 12 weeks, consecutively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuni Eka Anggraini

Collaborators

Gadjah Mada University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT0012023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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