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

Not Applicable

Completed

• Conditions: Telangiectasia

• Registration Number: NCT04795310
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-07-02
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-01
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-12
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity index of facial telangiectasia	6months	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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China