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

Not Applicable

• Conditions: Keloid
• Interventions: Other: corticosteroid injection; Device: Thermomechanical system with corticosteroids

• Registration Number: NCT04597060
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-08
• Status Verified: 2020-10
• Study Start: 2020-10
• Study First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-15
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-01
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Split Keloid - second side	corticosteroid injection	-
Split Keloid - first side	Thermomechanical system with corticosteroids	-

Primary Outcome Measures

Name	Time	Method
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
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.
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%
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
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%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Dermatology, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand