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

NCT07263100 | Completed DMC FDA Device

• 1 other identifier: RP009/66
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypertrophic Scar; Keloid; Laser

Keywords

Hypertrophic scar; Keloid; Laser

Outcome Measures

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)

  5 months

Secondary Outcomes (1)

• Japan Scar Workshop Scar Scale

  5 months

Study Arms (3)

Keloidal scar

ACTIVE COMPARATOR

Randomly assigned keloid scar to each intervention (IL KA)

Drug: Triamcinolone acetonide injection

Keloidal scar 2

EXPERIMENTAL

Randomly assigned keloid scar to each intervention (IL KA + ND YAG)

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

Keloidal scar 3

EXPERIMENTAL

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

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

Interventions

Triamcinolone acetonide injection DRUG

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

Keloidal scar

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

Intralesional corticosteroid injection combine with long-pulse Neodynium-doped Yttrium Aluminium Garnet Laser (Nd-YAG) (IL KA + ND YAG)

Keloidal scar 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Somdech Phra Nangchao Sirikit Hospital: lead

Study Sites (1)

Somdech Phra Nangchao Sirikit Hospital

Sattahip, Changwat Chon Buri, 20180, Thailand

Location

Related Publications (1)

• 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.

  PMID: 39373734 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Keloid

Interventions

Triamcinolone Acetonide; Lasers, Solid-State

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 4, 2025
• Study Start: May 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1st July 2025 - 31st Dec 2025
• Access Criteria: Patient demographic data and scar characteristics, severity can be shared upon requests by emailing to the main researchers and asking for permission

Locations

TH (1)