The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04597060

Enrollment

Registered

2020-10-22

Start date

2020-10-31

Completion date

2021-02-28

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloid

Keywords

Keloid, thermo-mechanical system

Brief summary

This study aims to assess the safety and efficacy of Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery for the treatment of Hypertrophic scars and Keloids.

Interventions

DEVICEThermomechanical system with corticosteroids

The device in this study using Novoxel - Tixel®

OTHERcorticosteroid injection

corticosteroid injection using TA 10mg/ml

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers without underlying disease * Patient with keloid age more than 6 months and keloid thickness more than 1 mm.

Exclusion criteria

* Dermatitis or infection on treatment area * Suspected cancer on treatment area * Immunocompromised host * Pregnancy or lactating woman * Recieved corticosteroid injection within 2 months

Design outcomes

Primary

Measure	Time frame	Description
Vancouver Scar Scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids	6 months	Vancouver Scar Scale between 0 to 13
Patient satisfaction quartile scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids	6 months	Patient satisfaction quartile scale from 0 - 100%
Physician evaluation quartile score - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids	6 months	Physician evaluation quartile score from 0-100%
Thickness by caliper (mm) - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids	6 months	cthickness by caliper in mm.
Antera Elevation Volume - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids	6 months	Measuring Antera Elevation Volume in mm3

Secondary

Measure	Time frame
Side effect of Triamcinolone acetonide injection	6 months
Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect	6 months

Countries

Thailand

Contacts

Primary ContactProf. Woraphong Manuskiatti, M.D.

woraphong.man@mahidol.ac.th+6624197000

Backup ContactChadakan Yan, M.D.

chadakanyan4090@gmail.com+66882334090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026