NCT04597060

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

September 8, 2020

Last Update Submit

October 15, 2020

Conditions

Keloid

Keywords

Keloid, thermo-mechanical system

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect

    6 months

  • Side effect of Triamcinolone acetonide injection

    6 months

Study Arms (2)

Split Keloid - first side

EXPERIMENTAL
Device: Thermomechanical system with corticosteroids

Split Keloid - second side

EXPERIMENTAL
Other: corticosteroid injection

Interventions

Thermomechanical system with corticosteroidsDEVICE

The device in this study using Novoxel - Tixel®

Split Keloid - first side
corticosteroid injectionOTHER

corticosteroid injection using TA 10mg/ml

Split Keloid - second side

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers without underlying disease
  • Patient with keloid age more than 6 months and keloid thickness more than 1 mm.

You may not qualify if:

  • Dermatitis or infection on treatment area
  • Suspected cancer on treatment area
  • Immunocompromised host
  • Pregnancy or lactating woman
  • Recieved corticosteroid injection within 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Keloid

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Prof. Woraphong Manuskiatti, M.D.

CONTACT

+6624197000woraphong.man@mahidol.ac.th

Chadakan Yan, M.D.

CONTACT

+66882334090chadakanyan4090@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2020

First Posted

October 22, 2020

Study Start

October 1, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)