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 Overview
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Brief Summary
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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.

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

Conditions
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Keloid

Intervention / Treatment
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* Device: Thermomechanical system with corticosteroids
* Other: corticosteroid injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Split Keloid - first side<br> | Device: Thermomechanical system with corticosteroids<br>* The device in this study using Novoxel - Tixel®<br>|
| Experimental: Split Keloid - second side<br> | Other: corticosteroid injection<br>* corticosteroid injection using TA 10mg/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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% | 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% | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect |  | 6 months | 
| Side effect of Triamcinolone acetonide injection |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keloid, thermo-mechanical system