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

NCT ID: NCT04795310

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-01-01

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) .

Detailed Description

Detailed Description has not been entered.

Conditions

Telangiectasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Pulsed dye laser

Intervention Type: DEVICE

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.

Intense Pulsed Light

Vascular wavelength bands of 530-650nm and 900-1200nm

Group Type: ACTIVE_COMPARATOR

Pulsed dye laser

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gang Wang

Chief of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gang Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Dermatology Derpartment of Xijing Hospital

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

XijingH-PF-20192074-C-1

Identifier Type: -

Identifier Source: org_study_id