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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-02-28

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.

Detailed Description

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Conditions

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Keloid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Split Keloid - first side

Group Type EXPERIMENTAL

Thermomechanical system with corticosteroids

Intervention Type DEVICE

The device in this study using Novoxel - Tixel®

Split Keloid - second side

Group Type EXPERIMENTAL

corticosteroid injection

Intervention Type OTHER

corticosteroid injection using TA 10mg/ml

Interventions

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Thermomechanical system with corticosteroids

The device in this study using Novoxel - Tixel®

Intervention Type DEVICE

corticosteroid injection

corticosteroid injection using TA 10mg/ml

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Woraphong Manuskiatti, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Prof. Woraphong Manuskiatti, M.D.

Role: CONTACT

+6624197000 ext. 4333

Chadakan Yan, M.D.

Role: CONTACT

+66882334090

Other Identifiers

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Si 719/2018

Identifier Type: -

Identifier Source: org_study_id

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