The Vascularity Changes of Scars With Laser Therapy

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03986346
• Collaborator: Chinese University of Hong Kong (Other), Southwest Hospital, China (Other)
• Enrollment: 45
• Locations: 2
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site: 22.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Scar	Device: pulsed dye laser; Other: standardized care	N/A

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

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Vascularity Changes of Scars With Receiving Pulsed Dye Laser
• Actual Study Start Date: May 31, 2019
• Actual Primary Completion Date: Feb 27, 2020
• Actual Study Completion Date: Feb 27, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. scar erythema [3 months]

   Dermoscopy captures the scar photo and measures degrees of scar erythema.

2. scar blood flow [3 months]

   Ultrasound measures blood flow in scar tissues

3. scar thickness [3 months]

   Ultrasound measures scar thickness.

Secondary Outcome Measures

1. patient and observer scar assessment scale (POSAS) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Hospital	Chongqing		China
2	Prince of Wales Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• The Hong Kong Polytechnic University
• Chinese University of Hong Kong
• Southwest Hospital, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT03986346
• Other Study ID Numbers: HSEARS20190402002
• First Posted: Jun 14, 2019
• Last Update Posted: Mar 10, 2020
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Hong Kong Polytechnic University: hypertrophic scar; pulsed dye laser
• Additional relevant MeSH terms: Hypertrophy; Cicatrix, Hypertrophic

Study Results

No Results Posted as of Mar 10, 2020