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Completed

NCT Number: NCT04795310

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

Detailed Description has not been entered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Intense pulsed light

Primary outcomes

  1. Severity index of facial telangiectasia

    Time frame: 6months

    • 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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 12, 2021
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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