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CompletedNCT07263100Updated Dec 4, 2025

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

An interventional study of Triamcinolone acetonide injection and Fotona dynamis: Long pulse Nd YAG + Er YAG laser in Hypertrophic Scar, Keloid and Laser, sponsored by Somdech Phra Nangchao Sirikit Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Somdech Phra Nangchao Sirikit Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertrophic Scar
  • Keloid
  • Laser

Keywords

  • Hypertrophic scar
  • Keloid
  • Laser
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Keloidal scar

    Randomly assigned keloid scar to each intervention (IL KA)

    Drug: Triamcinolone acetonide injection

  • 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

  • Experimental
    Keloidal scar 3

    Randomly assigned keloid scar to each intervention (ILKA + Er YAG)

    Device: Fotona Dynamis: Long pulse Nd YAG + Er YAG laser

Interventions

  • DrugTriamcinolone acetonide injection

    Long-pulse ND YAG and Erbium YAG laser device: Fotona Dynamis

  • DeviceFotona 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)

  • DeviceFotona Dynamis: Long pulse Nd YAG + Er YAG laser

    Intralesional corticosteroid injection combine with Erbium Yttrium Aluminium Garnet Laser (Er-YAG) (IL KA + Er YAG)

05

What researchers measure

Primary outcomes

  1. Vancouver scar scale

    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)

    Time frame: 5 months

Secondary outcomes

  1. Japan Scar Workshop Scar Scale

    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)

    Time frame: 5 months

06

Study locations

1 site
  • Somdech Phra Nangchao Sirikit Hospital
    Sattahip, Changwat Chon Buri 20180, Thailand
07

References and documents

Publications

  • Park JH, Jeong JW, Park JU. Efficacy of Nd:YAG Laser and Intralesional Triamcinolone Injection Combination Therapy in the Postoperative Management of Keloids. Aesthetic Plast Surg. 2025 Jan;49(2):576-583. doi: 10.1007/s00266-024-04433-z. Epub 2024 Oct 7. PubMed 39373734 ↗

Individual participant data

Plan to share: Yes — Patient demographic data and scar characteristics, severity can be shared upon requests

Supporting information: Study protocol, Sap, Icf, Csr

08

Registry details

Key details

Study ID
NCT07263100
Lead sponsor
Somdech Phra Nangchao Sirikit Hospital
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
May 1, 2023
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024
Last update
Dec 4, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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