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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04597060
• Other study ID #: Si 719/2018
• Status: Recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: February 2021

Study information

• Verified date: October 2020
• Source: Mahidol University
• Contact: Prof. Woraphong Manuskiatti, M.D.
• Phone: +6624197000
• Email: woraphong.man[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Keloid

Intervention

Device:
• Thermomechanical system with corticosteroids
The device in this study using Novoxel - Tixel®

Other:
• corticosteroid injection
corticosteroid injection using TA 10mg/ml

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect		6 months
Secondary	Side effect of Triamcinolone acetonide injection		6 months