Efficacy and Safety of Ultrapulse Carbon Dioxide Laser Treatment in Eyelid Tumors

Recruiting

• Conditions: Eyelid Tumor; Pigmented Nevi; Xanthelasma Palpebrarum; Keratosis
• Interventions: Procedure: Ultra-pulsed Carbon Dioxide Laser

• Registration Number: NCT06206681
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This study aims to assess the long-term efficacy and safety of ultrapulse carbon dioxide (CO₂) laser excision in the treatment of eyelid tumors, including xanthelasma, pigmented nevi, keratoses, and so on.

Detailed Description

-Background: The assessment of the efficacy and safety of Ultrapulse CO₂ laser in treating eyelid lesions is crucial for clinical applications. This study aims to evaluate the effectiveness of super-pulsed CO₂ laser in treating different types of eyelid lesions, particularly marginal and large lesions, to provide comprehensive clinical guidance and decision support.

-Main Objectives: A retrospective analysis of the efficacy and safety of Ultrapulse CO₂ laser treatment for various types of eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.

-Study Design: This study will include 1000 patients diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on. All patients undergoing Ultrapulse CO₂ laser treatment. The evaluation will focus on the efficacy and safety of Ultrapulse CO₂ laser treatment for different types of eyelid lesions.

-Study Population and Anticipated Enrollment: Patients with eyelid lesions (n=1000)

-Inclusion Criteria: Clinically diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.

No history of photosensitivity, bleeding, or coagulation disorders Willing to attend follow-up appointments as scheduled

-Exclusion Criteria: Presence of infection in the target area Allergy to lidocaine Keloid-prone or poor skin repair ability Pregnant or lactating Recent history of severe infectious diseases, active skin diseases, or major diseases affecting the cardiovascular, liver, kidney, endocrine, and hematopoietic systems History of malignant tumors or immune system disorders

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-10-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Clinically diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.
• No history of photosensitivity, bleeding, or coagulation disorders
• Willing to attend follow-up appointments as scheduled

Exclusion Criteria

• Presence of infection in the target area
• Allergy to lidocaine
• Keloid-prone or poor skin repair ability
• Pregnant or lactating
• Recent history of severe infectious diseases, active skin diseases, or major diseases affecting the cardiovascular, liver, kidney, endocrine, and hematopoietic systems
• History of malignant tumors or immune system disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrapulse Carbon Dioxide Laser	Ultra-pulsed Carbon Dioxide Laser	The study investigates the use of the Ultrapulse Carbon Dioxide Laser for the excision of eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on.

Primary Outcome Measures

Name	Time	Method
Clearance rate	12 months	The lesion clearance rate was classified as the proportion of the lesion cleared (\<50%; 50-75%; 76-99%; or \>99%).
Recurrence rate	12 months	Recurrence was defined as the regrowth of a new xanthelasma lesion within the previously excised area.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction score	12 months	Patient satisfaction was evaluated subjectively by the physician on a f ve-point scale, as follows: 0=no change; 1=minor improvement; 2=moderate improvement; 3=marked improvement; 4=near-total or total improvement.
Investigator's Global Assessment (IGA) score	12 months	Investigator's Global Assessment (IGA) score for measuring improvement in clinical outcomes: 1=worsened; 2=no change; 3=minor improvement; 4=moderate improvement; 5=marked improvement; 6=near-total improvement; and 7=total improvement.
Number of treatment sessions	12 months	Number of treatment sessions for complete clearance
Postoperative complications	12 months	Lesion recurred, minor trichiasis, partial sparse to absent eyelashes, hypertrophic scar, hyperpigmentation

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guanzhou, China