Hypertrophic ScarNCT07263100
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
A study testing Triamcinolone acetonide injection and Fotona dynamis: Long pulse Nd YAG + Er YAG laser in people with Hypertrophic Scar and Keloid, run by Somdech Phra Nangchao Sirikit Hospital at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Scar, Keloid, Laser
- What is being tested?
- Triamcinolone acetonide injection and Fotona dynamis: Long pulse Nd YAG + Er YAG laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual with hypertrophic or keloid scars on any location
- Size of hypertrophic or keloid scars not larger than 20 cms in diameter
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Somdech Phra Nangchao Sirikit Hospital
Sattahip, Changwat Chon Buri, 20180
About this study
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
- Being tested
- Triamcinolone acetonide injection, Fotona dynamis: Long pulse Nd YAG + Er YAG laser
- Keywords
- Hypertrophic scar, Keloid, Laser
- Medical subject headings
- Cicatrix, Hypertrophic, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonide injectionDrug
Long-pulse ND YAG and Erbium YAG laser device: Fotona Dynamis
Fotona dynamis: Long pulse Nd YAG + Er YAG laserDevice
Intralesional corticosteroid injection combine with long-pulse Neodynium-doped Yttrium Aluminium Garnet Laser (Nd-YAG) (IL KA + ND YAG)
Fotona Dynamis: Long pulse Nd YAG + Er YAG laserDevice
Intralesional corticosteroid injection combine with Erbium Yttrium Aluminium Garnet Laser (Er-YAG) (IL KA + Er YAG)
| Study group | Role | What they receive |
|---|---|---|
| Keloidal scar | Active comparator | Randomly assigned keloid scar to each intervention (IL KA) Receives: Drug: Triamcinolone acetonide injection |
| Keloidal scar 2 | Experimental | Randomly assigned keloid scar to each intervention (IL KA + ND YAG) Receives: Device: Fotona dynamis: Long pulse Nd YAG + Er YAG laser |
| Keloidal scar 3 | Experimental | Randomly assigned keloid scar to each intervention (ILKA + Er YAG) Receives: Device: Fotona Dynamis: Long pulse Nd YAG + Er YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- Classification scoring range 0-5 = matured scars 6-15 = hypertrophic scars 16-25 = keloids
- Evaluation for treatment \& follow ups scoring range from 0-18 (the more scores resembling the more severity)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 May 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somdech Phra Nangchao Sirikit Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263100
- Sponsor's protocol ID
- RP009/66
- Status last verified
- Dec 2025
- First submitted
- 12 Nov 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Patient demographic data and scar characteristics, severity can be shared upon requests
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07263100
- Acronym / sponsor ID
- RP009/66
- Conditions
- Hypertrophic Scar, Keloid, Laser
- Keywords
- Hypertrophic scar, Keloid, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Somdech Phra Nangchao Sirikit HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Keloidal scar | Active comparator | Drug: Triamcinolone acetonide injectionRandomly assigned keloid scar to each intervention (IL KA) |
| Keloidal scar 2 | Experimental | Device: Fotona dynamis: Long pulse Nd YAG + Er YAG laserRandomly assigned keloid scar to each intervention (IL KA + ND YAG) |
| Keloidal scar 3 | Experimental | Device: Fotona Dynamis: Long pulse Nd YAG + Er YAG laserRandomly assigned keloid scar to each intervention (ILKA + Er YAG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individual with hypertrophic or keloid scars on any location
- Size of hypertrophic or keloid scars not larger than 20 cms in diameter
Key exclusion criteria (6 listed)
- Any topical or procedural treatment on scar in last 6 months
- Current corticosteroid use
- Bleeding disorders or coagulopathies
- Pregnancy or nursing
- Chronic kidney diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone acetonide injectionLong-pulse ND YAG and Erbium YAG laser device: Fotona Dynamis | Drug | Keloidal scar |
| Fotona dynamis: Long pulse Nd YAG + Er YAG laserIntralesional corticosteroid injection combine with long-pulse Neodynium-doped Yttrium Aluminium Garnet Laser (Nd-YAG) (IL KA + ND YAG) | Device | Keloidal scar 2 |
| Fotona Dynamis: Long pulse Nd YAG + Er YAG laserIntralesional corticosteroid injection combine with Erbium Yttrium Aluminium Garnet Laser (Er-YAG) (IL KA + Er YAG) | Device | Keloidal scar 3 |
Primary outcome
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)
1 secondary outcome
Japan Scar Workshop Scar Scale
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 39373734Park 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.
- Individual participant dataSharing planned: Yes. Patient demographic data and scar characteristics, severity can be shared upon requests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone acetonide injection and Fotona dynamis: Long pulse Nd YAG + Er YAG laser in people with Hypertrophic Scar and Keloid, run by Somdech Phra Nangchao Sirikit Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver scar scale (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07263100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.