Clinical Observation of Pulsed Dye Laser and Intense Pulsed Light in Treating Facial Telangiectasia
Primary Purpose
Telangiectasia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulsed dye laser
Sponsored by
About this trial
This is an interventional treatment trial for Telangiectasia focused on measuring Facial Telangiectasia, Pulsed dye laser (PDL), Intense Pulsed Light
Eligibility Criteria
Inclusion Criteria:
- Subjects must be clinically diagnosed with facial telangiectasia
- No other external treatment was performed before the injury was treated
Exclusion Criteria:
- subjects with a recent history of exposure to sunlight
- subjects allergic to topical anesthesia
- subjects with scar constitution
- subjects with skin malignant tumors or precancerous lesions
- subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc
- subjects who Pregnant or breast feeding
- subjects with recent skin infections (such as viruses, bacteria, etc.)
- other methods are being used to treat subjects with similar diseases
- subject who have taken isotretinoin A in the past year
- subject with facial dermatitis
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pulsed Dye Laser
Intense Pulsed Light
Arm Description
PDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD)
Vascular wavelength bands of 530-650nm and 900-1200nm
Outcomes
Primary Outcome Measures
Severity index of facial telangiectasia
minimal, focal visible telangiectasia in 5-10% of anatomic area
focal visible telangiectasia in11-20% of an anatomic area
focal visible telangiectasia in 21-30% of anatomic area
visible telangiectasia in 31-40% of anatomic area
visible telangiectasia in 41-50% of anatomic area
moderately severe telangiectasia in 51-60% of anatomic area
moderately severe telangiectasia in 61-70% of anatomic area
severe telangiectasia in 71-80% of anatomic area
severe telangiectasia in 81-90% of anatomic area
severe and diffuse facial telangiectasia in entire anatomic area for facial telangiectasia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04795310
Brief Title
Clinical Observation of Pulsed Dye Laser and Intense Pulsed Light in Treating Facial Telangiectasia
Official Title
A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser and Intense Pulsed Light With Different Wavelength Bands in the Treatment of Facial Telangiectasia: a Retrospective, Self-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Facial telangiectasia is one of the common skin vascular lesions characterized by dilated cutaneous vasculatures in the skin surface or mucous membranes. Lesions are generally sensitive to exposure of cold, heat and sun. Those distinct small dilated blood vessels are cosmetically disfiguring for patients which require an effective solution. The traditional management options for facial telangiectasia include cryotherapy, CO2 laser, topical agent, oral estrogens, electrosurgery, and radioactive treatment. However, inadequate outcomes and severe adversaries are the major concerns to patients and physicians.
Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis.
The intense pulsed light source is an alternative or supplement to the already existing laser devices that are part of the laser surgeon's repertoire. The broad wavelength spectrum and variable pulse duration allow greater penetration depths to be reached without damaging surrounding tissue and thus enhance the versatility of this system.
This study aims to compare the clearance efficacy of facial telangiectasia using PDL (595nm) with IPL configured by various wavelength bands, including M22 vascular filter (530-650nm and 900-1200nm), M22 560 (560-1200nm), M22 590 (590-1200nm) .
Detailed Description
Detailed Description has not been entered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telangiectasia
Keywords
Facial Telangiectasia, Pulsed dye laser (PDL), Intense Pulsed Light
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed Dye Laser
Arm Type
Experimental
Arm Description
PDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD)
Arm Title
Intense Pulsed Light
Arm Type
Active Comparator
Arm Description
Vascular wavelength bands of 530-650nm and 900-1200nm
Intervention Type
Device
Intervention Name(s)
Pulsed dye laser
Other Intervention Name(s)
Intense pulsed light
Intervention Description
PDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD).
IPL device (M22, Lumenis Limited, Yokneam, Israel) with integration of sapphire ChillTip system for epidermal cooling were used in the study. Three wavelength bands were configured: 560-1200 nm, 590-1200 nm, and vascular wavelength bands of 530-650nm and 900-1200nm. All the treatment handpieces had a spot size of 15mm×35mm, fluence of 9-17J/cm², pulse duration of 4.0-6.0ms and pulse delay of 20-40ms, underwent the M22 advanced optimal pulse technology (AOPT) treatment.
Primary Outcome Measure Information:
Title
Severity index of facial telangiectasia
Description
minimal, focal visible telangiectasia in 5-10% of anatomic area
focal visible telangiectasia in11-20% of an anatomic area
focal visible telangiectasia in 21-30% of anatomic area
visible telangiectasia in 31-40% of anatomic area
visible telangiectasia in 41-50% of anatomic area
moderately severe telangiectasia in 51-60% of anatomic area
moderately severe telangiectasia in 61-70% of anatomic area
severe telangiectasia in 71-80% of anatomic area
severe telangiectasia in 81-90% of anatomic area
severe and diffuse facial telangiectasia in entire anatomic area for facial telangiectasia
Time Frame
6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be clinically diagnosed with facial telangiectasia
No other external treatment was performed before the injury was treated
Exclusion Criteria:
subjects with a recent history of exposure to sunlight
subjects allergic to topical anesthesia
subjects with scar constitution
subjects with skin malignant tumors or precancerous lesions
subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc
subjects who Pregnant or breast feeding
subjects with recent skin infections (such as viruses, bacteria, etc.)
other methods are being used to treat subjects with similar diseases
subject who have taken isotretinoin A in the past year
subject with facial dermatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Wang, Prof
Organizational Affiliation
Dermatology Derpartment of Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Observation of Pulsed Dye Laser and Intense Pulsed Light in Treating Facial Telangiectasia
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