Hypertrophic ScarNCT03986346
The Vascularity Changes of Scars With Laser Therapy
A study testing pulsed dye laser and standardized care in people with Hypertrophic Scar, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
Trial summary
The purpose of this study is to explore the effects of pulsed dye laser on managing scar vascularity and thickness. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- pulsed dye laser and standardized care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 May 2019to 27 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertrophic Scar
- Being tested
- pulsed dye laser, standardized care
- Keywords
- hypertrophic scar, pulsed dye laser
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed dye laserDevice
The scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury.
standardized careOther
the scar will receive standardized care such as scar massage.
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Experimental | Participants in this group receive pulsed dye laser to treat the scar. Receives: Device: pulsed dye laser; Other: standardized care |
| Control group | Active comparator | Participants in this group receive standardized care. Receives: Other: standardized care |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar erythema
Dermoscopy captures the scar photo and measures degrees of scar erythema.
Measured: 3 months
scar blood flow
Ultrasound measures blood flow in scar tissues
Measured: 3 months
scar thickness
Ultrasound measures scar thickness.
Measured: 3 months
Secondary outcomes (1)
patient and observer scar assessment scale (POSAS)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start31 May 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, Southwest Hospital, China
- Responsible party
- Sponsor
- Investigators
- Cecilia Li-tsang, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986346
- Sponsor's protocol ID
- HSEARS20190402002
- Status last verified
- May 2019
- First submitted
- 24 May 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng H, Li-Tsang CWP. Measurement of vascularity in the scar: A systematic review. Burns. 2019 Sep;45(6):1253-1265. doi: 10.1016/j.burns.2018.10.026. Epub 2018 Dec 10.
PubMed 30545695
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vascularity Changes of Scars With Receiving Pulsed Dye Laser
- ClinicalTrials.gov ID
- NCT03986346
- Acronym / sponsor ID
- HSEARS20190402002
- Conditions
- Hypertrophic Scar
- Keywords
- hypertrophic scar, pulsed dye laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, Southwest Hospital, China
- Study start
- 31 May 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the effects of pulsed dye laser on managing scar vascularity and thickness.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser group | Experimental | Device: pulsed dye laser, Other: standardized careParticipants in this group receive pulsed dye laser to treat the scar. |
| Control group | Active comparator | Other: standardized careParticipants in this group receive standardized care. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulsed dye laserThe scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury. | Device | Laser group |
| standardized carethe scar will receive standardized care such as scar massage. | Other | Control group, Laser group |
Primary outcome
scar erythema
Time frame: 3 months
Dermoscopy captures the scar photo and measures degrees of scar erythema.
scar blood flow
Time frame: 3 months
Ultrasound measures blood flow in scar tissues
scar thickness
Time frame: 3 months
Ultrasound measures scar thickness.
1 secondary outcome
patient and observer scar assessment scale (POSAS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 30545695Deng H, Li-Tsang CWP. Measurement of vascularity in the scar: A systematic review. Burns. 2019 Sep;45(6):1253-1265. doi: 10.1016/j.burns.2018.10.026. Epub 2018 Dec 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Li-tsang principal investigator
The Hong Kong Polytechnic University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed dye laser and standardized care in people with Hypertrophic Scar, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scar erythema (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03986346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.