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

NCT04795310 | Completed DMC

• 1 other identifier: XijingH-PF-20192074-C-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis.
3. 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) .

Conditions

Telangiectasia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Severity index of facial telangiectasia

  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

  6months

Study Arms (2)

Pulsed Dye Laser

EXPERIMENTAL

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

Intense Pulsed Light

ACTIVE COMPARATOR

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

Device: Pulsed dye laser

Interventions

Pulsed dye laser 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.

Also known as: Intense pulsed light

Intense Pulsed Light; Pulsed Dye Laser

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be clinically diagnosed with facial telangiectasia
• No other external treatment was performed before the injury was treated

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Telangiectasis

Interventions

Lasers, Dye; Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Phototherapy; Therapeutics

Study Officials

• Gang Wang, Prof

  Dermatology Derpartment of Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Dermatology

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: March 12, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

CN (1)