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CompletedNCT04795310Updated Mar 12, 2021

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

An interventional study of Pulsed dye laser in Telangiectasia, sponsored by Xijing Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-12.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2019, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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) .
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02

Conditions studied

  • Telangiectasia

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Keywords

  • Facial Telangiectasia
  • Pulsed dye laser (PDL)
  • Intense Pulsed Light
03

In context

Telangiectasis

153 studies on the registry are indexed under Telangiectasis; 16 are open to participants now.

This study's enrollment of 150 is above the median of 30 across 107 interventional studies indexed under Telangiectasis.

Browse Telangiectasis studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (actual)

Study arms

  • 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

  • Active comparator
    Intense Pulsed Light

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

    Device: Pulsed dye laser

Interventions

  • DevicePulsed 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.

    Also known as: Intense pulsed light

06

What researchers measure

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

    Time frame: 6months

07

Study locations

1 site
  • Xijing Hospital
    Xi'an, Shaanxi 710032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04795310
Lead sponsor
Xijing Hospital
Responsible party
Gang Wang (Chief of Dermatology, Xijing Hospital) — Principal investigator
First posted
Mar 12, 2021
Start date
Jan 1, 2019
Primary completion
Dec 31, 2019
Completion
Jan 1, 2020
Last update
Mar 12, 2021

Study contacts

Gang Wang, Prof
principal investigator · Dermatology Derpartment of Xijing Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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