The Vascularity Changes of Scars With Laser Therapy

March 6, 2020 updated by: The Hong Kong Polytechnic University

The Vascularity Changes of Scars With Receiving Pulsed Dye Laser

The purpose of this study is to explore the effects of pulsed dye laser on managing scar vascularity and thickness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pulsed dye laser is increasingly used in clinical settings to manage scars and shows promising outcomes.The pulsed dye laser targets at micro-vascular structures in scar tissues. This study aims to explore the vascularity changes in scars with pulsed dye laser during the scar formation process.

Study Type

Interventional

Enrollment (Actual)

45

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 Locations

  • China
      • Chongqing, China
        • Southwest Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

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

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scars caused by burn injury or related trauma;
  • wound healing days over 3 weeks;
  • days post injury less than 1 year;
  • ability and willingness to comply with all the treatment and assessment procedures.

Exclusion Criteria:

  • history of steroid injection or graft surgery;
  • history of keloid scarring;
  • open wound or active infection;
  • conditions that affect wound healing, such as diabetes mellitus.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laser group
Participants in this group receive pulsed dye laser to treat the scar.
Device: pulsed dye laser
The scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury.
Other: standardized care
the scar will receive standardized care such as scar massage.
ACTIVE_COMPARATOR: Control group
Participants in this group receive standardized care.
Other: standardized care
the scar will receive standardized care such as scar massage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scar erythema
Time Frame: 3 months
Dermoscopy captures the scar photo and measures degrees of scar erythema.
3 months
scar blood flow
Time Frame: 3 months
Ultrasound measures blood flow in scar tissues
3 months
scar thickness
Time Frame: 3 months
Ultrasound measures scar thickness.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient and observer scar assessment scale (POSAS)
Time Frame: 3 months
The POSAS measures scar vascularity, pigmentation, pigmentation, thickness, relief, pliability and surface area. Every parameter ranges from 1 to 10, and higher score indicates worse scar performance in that parameter. The total score of POSAS is calculated by summing all the parameters' scores.
3 months

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Collaborators

Chinese University of Hong Kong
Southwest Hospital, China

Investigators

  • Principal Investigator: Cecilia Li-tsang, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

May 31, 2019

Primary Completion (ACTUAL)

February 27, 2020

Study Completion (ACTUAL)

February 27, 2020

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (ACTUAL)

June 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20190402002

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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