Back to resultsThe Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids
Primary Purpose
Keloid
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Thermomechanical system with corticosteroids
corticosteroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Keloid focused on measuring Keloid, thermo-mechanical system
Eligibility Criteria
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
Sites / Locations
- Department of Dermatology, Siriraj Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Split Keloid - first side
Split Keloid - second side
Arm Description
Outcomes
Primary Outcome Measures
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.
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
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
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%
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%
Secondary Outcome Measures
Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect
Side effect of Triamcinolone acetonide injection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04597060
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Keloid, thermo-mechanical system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Split Keloid - first side
Arm Type
Experimental
Arm Title
Split Keloid - second side
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Thermomechanical system with corticosteroids
Intervention Description
The device in this study using Novoxel - Tixel®
Intervention Type
Other
Intervention Name(s)
corticosteroid injection
Intervention Description
corticosteroid injection using TA 10mg/ml
Primary Outcome Measure Information:
Title
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
Description
cthickness by caliper in mm.
Time Frame
6 months
Title
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
Description
Vancouver Scar Scale between 0 to 13
Time Frame
6 months
Title
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
Description
Measuring Antera Elevation Volume in mm3
Time Frame
6 months
Title
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
Description
Patient satisfaction quartile scale from 0 - 100%
Time Frame
6 months
Title
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
Description
Physician evaluation quartile score from 0-100%
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect
Time Frame
6 months
Title
Side effect of Triamcinolone acetonide injection
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Woraphong Manuskiatti, M.D.
Phone
+6624197000
Ext
4333
Email
woraphong.man@mahidol.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Chadakan Yan, M.D.
Phone
+66882334090
Email
chadakanyan4090@gmail.com
Facility Information:
Facility Name
Department of Dermatology, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woraphong Manuskiatti, M.D.
First Name & Middle Initial & Last Name & Degree
Rungsima Wanitphakdeedacha, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids
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