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

Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206681
• Other study ID #: 2023KYPJ286
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: Dingqiao Wang, PhD
• Phone: 13976031334
• Email: wangdingqiao[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eyelid Tumor
• Keratosis
• Nevus, Pigmented
• Pigmented Nevi

Intervention

Procedure:
• Ultra-pulsed Carbon Dioxide Laser
Excision of eyelid lesion

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guanzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance rate	The lesion clearance rate was classified as the proportion of the lesion cleared (<50%; 50-75%; 76-99%; or >99%).	12 months
Primary	Recurrence rate	Recurrence was defined as the regrowth of a new xanthelasma lesion within the previously excised area.	12 months
Secondary	Postoperative complications	Lesion recurred, minor trichiasis, partial sparse to absent eyelashes, hypertrophic scar, hyperpigmentation	12 months
Secondary	Investigator's Global Assessment (IGA) score	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.	12 months
Secondary	Patient satisfaction score	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.	12 months
Secondary	Number of treatment sessions	Number of treatment sessions for complete clearance	12 months