Comparative Study Between Intralesional Corticosteroid Injection Alone and Combined Intralesional Corticosteroid Injection With Either Long-pluse Nd YAG or Erbium Yag for Treating Hypertrophic or Keloid Scars

December 3, 2025 updated by: Somdech Phra Nangchao Sirikit Hospital
To compare the effectiveness of hypertrophic or keloid scar treatment with either intralesional corticosteroid injection alone or combined intralesional corticosteroid injection with either long-pulse ND YAG or Erbium YAG

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Thailand
    • Changwat Chon Buri
      • Sattahip, Changwat Chon Buri, Thailand, 20180
        • Somdech Phra Nangchao Sirikit Hospital

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

No

Description

Inclusion Criteria:

  • Individual with hypertrophic or keloid scars on any location
  • Size of hypertrophic or keloid scars not larger than 20 cms in diameter

Exclusion Criteria:

  • Any topical or procedural treatment on scar in last 6 months
  • Current corticosteroid use
  • Bleeding disorders or coagulopathies
  • Pregnancy or nursing
  • Chronic kidney diseases
  • Chronic liver diseases

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Keloidal scar
Randomly assigned keloid scar to each intervention (IL KA)
Drug: Triamcinolone acetonide injection
Long-pulse ND YAG and Erbium YAG laser device: Fotona Dynamis
Experimental: Keloidal scar 2
Randomly assigned keloid scar to each intervention (IL KA + ND YAG)
Device: Fotona dynamis: Long pulse Nd YAG + Er YAG laser
Intralesional corticosteroid injection combine with long-pulse Neodynium-doped Yttrium Aluminium Garnet Laser (Nd-YAG) (IL KA + ND YAG)
Experimental: Keloidal scar 3
Randomly assigned keloid scar to each intervention (ILKA + Er YAG)
Device: Fotona Dynamis: Long pulse Nd YAG + Er YAG laser
Intralesional corticosteroid injection combine with Erbium Yttrium Aluminium Garnet Laser (Er-YAG) (IL KA + Er YAG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vancouver scar scale
Time Frame: 5 months
Vancouver scar scale to evaluate scar severity of keloid scar assessing 4 variations including vascularity, pigmentation, pliability, height scoring range from 0-13 (the more scores resembling the more severity)
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Japan Scar Workshop Scar Scale
Time Frame: 5 months

Japan Scar Workshop Scar Scale to evaluate scar severity of keloid scar assessing 2 main domains (risk factors and presenting symptoms) by 2 tables

  1. Classification scoring range 0-5 = matured scars 6-15 = hypertrophic scars 16-25 = keloids
  2. Evaluation for treatment & follow ups scoring range from 0-18 (the more scores resembling the more severity)
5 months

Collaborators and Investigators

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

Sponsor

Somdech Phra Nangchao Sirikit Hospital

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 (Actual)

May 1, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP009/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient demographic data and scar characteristics, severity can be shared upon requests

IPD Sharing Time Frame

1st July 2025 - 31st Dec 2025

IPD Sharing Access Criteria

Patient demographic data and scar characteristics, severity can be shared upon requests by emailing to the main researchers and asking for permission

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • 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

Yes

product manufactured in and exported from the U.S.

Yes

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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