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

October 15, 2020 updated by: Woraphong Manuskiatti, M.D., Mahidol University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Department of Dermatology, Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
Physician evaluation quartile score from 0-100%
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (ACTUAL)

October 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 719/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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