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

Mahidol University

Status: Unknown

Conditions: Keloid

Treatments: Other: corticosteroid injection; Device: Thermomechanical system with corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT04597060

Si 719/2018

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Split Keloid - first side

Experimental group

Treatment:

Device: Thermomechanical system with corticosteroids

Split Keloid - second side

Experimental group

Treatment:

Other: corticosteroid injection