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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04795310
Other study ID # XijingH-PF-20192074-C-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2020

Study information

Verified date March 2021
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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) .


Description:

Detailed Description has not been entered.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 1, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severity index of facial telangiectasia 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
6months
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