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.
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.
|
The scar will receive PDL 585 nm using a 7 mm spot size.
First treatment will be within 1 year post injury.
the scar will receive standardized care such as scar massage.
|
|
ACTIVE_COMPARATOR: Control group
Participants in this group receive 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.
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.
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.