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 University25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Keloid

Interventions

Thermomechanical system with corticosteroidsDEVICE

The device in this study using Novoxel - Tixel®

corticosteroid injectionOTHER

corticosteroid injection using TA 10mg/ml

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

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

cthickness by caliper in mm.

Time frame: 6 months

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

Vancouver Scar Scale between 0 to 13

Time frame: 6 months

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

Measuring Antera Elevation Volume in mm3

Time frame: 6 months

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

Patient satisfaction quartile scale from 0 - 100%

Time frame: 6 months

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

Physician evaluation quartile score from 0-100%

Time frame: 6 months

Secondary Outcomes

Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect

Central Contacts

Prof. Woraphong Manuskiatti, M.D.

CONTACT

+6624197000 woraphong.man@mahidol.ac.th

Chadakan Yan, M.D.

CONTACT

+66882334090 chadakanyan4090@gmail.com

Data from ClinicalTrials.gov

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