The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids
NCT ID: NCT04597060
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2020-10-31
2021-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Split Keloid - first side
Thermomechanical system with corticosteroids
The device in this study using Novoxel - Tixel®
Split Keloid - second side
corticosteroid injection
corticosteroid injection using TA 10mg/ml
Interventions
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Thermomechanical system with corticosteroids
The device in this study using Novoxel - Tixel®
corticosteroid injection
corticosteroid injection using TA 10mg/ml
Eligibility Criteria
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Inclusion Criteria
* Patient with keloid age more than 6 months and keloid thickness more than 1 mm.
Exclusion Criteria
* Suspected cancer on treatment area
* Immunocompromised host
* Pregnancy or lactating woman
* Recieved corticosteroid injection within 2 months
18 Years
70 Years
ALL
Yes
Sponsors
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Mahidol University
OTHER
Responsible Party
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Woraphong Manuskiatti, M.D.
Professor
Locations
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Department of Dermatology, Siriraj Hospital, Mahidol University
Bangkok, , Thailand
Countries
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Central Contacts
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Other Identifiers
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Si 719/2018
Identifier Type: -
Identifier Source: org_study_id
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