Clinical Observation of Pulsed Dye Laser and Intense Pulsed Light in Treating Facial Telangiectasia

• ClinicalTrials.gov Identifier: NCT04795310
• Recruitment Status: Completed
• First Posted: March 12, 2021
• Last Update Posted: March 12, 2021
• Sponsor: Xijing Hospital
• Information provided by (Responsible Party): Gang Wang, Xijing Hospital

Study Description

Brief Summary:

1. 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.

2. 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.

3. 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) .

Condition or disease	Intervention/treatment	Phase
Telangiectasia	Device: Pulsed dye laser	Not Applicable

Detailed Description:

Detailed Description has not been entered.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: January 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pulsed Dye Laser; 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)	Device: Pulsed dye laser; 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.; Other Name: Intense pulsed light
Active Comparator: Intense Pulsed Light; Vascular wavelength bands of 530-650nm and 900-1200nm	Device: Pulsed dye laser; 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.; Other Name: Intense pulsed light

Outcome Measures

Primary Outcome Measures :

1. Severity index of facial telangiectasia [ Time Frame: 6months ]
   1. minimal, focal visible telangiectasia in 5-10% of anatomic area
   2. focal visible telangiectasia in11-20% of an anatomic area
   3. focal visible telangiectasia in 21-30% of anatomic area
   4. visible telangiectasia in 31-40% of anatomic area
   5. visible telangiectasia in 41-50% of anatomic area
   6. moderately severe telangiectasia in 51-60% of anatomic area
   7. moderately severe telangiectasia in 61-70% of anatomic area
   8. severe telangiectasia in 71-80% of anatomic area
   9. severe telangiectasia in 81-90% of anatomic area
   10. severe and diffuse facial telangiectasia in entire anatomic area for facial telangiectasia

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Shaanxi

Xijing Hospital

Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Xijing Hospital

Investigators

• Principal Investigator: Gang Wang, Prof; Dermatology Derpartment of Xijing Hospital

More Information

• Responsible Party: Gang Wang, Chief of Dermatology, Xijing Hospital
• ClinicalTrials.gov Identifier: NCT04795310
• Other Study ID Numbers: XijingH-PF-20192074-C-1
• First Posted: March 12, 2021
• Last Update Posted: March 12, 2021
• Last Verified: March 2021

• 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

Keywords provided by Gang Wang, Xijing Hospital:

Facial Telangiectasia; Pulsed dye laser (PDL); Intense Pulsed Light

Additional relevant MeSH terms:

Telangiectasis; Vascular Diseases; Cardiovascular Diseases