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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06206681
Enrollment
1000
Registered
2024-01-16
Start date
2022-11-01
Completion date
2025-09-01
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eyelid Tumor, Keratosis, Pigmented Nevi, Xanthelasma Palpebrarum

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

Interventions

PROCEDUREUltra-pulsed Carbon Dioxide Laser

Excision of eyelid lesion

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clearance rate12 monthsThe lesion clearance rate was classified as the proportion of the lesion cleared (\<50%; 50-75%; 76-99%; or \>99%).
Recurrence rate12 monthsRecurrence was defined as the regrowth of a new xanthelasma lesion within the previously excised area.

Secondary

MeasureTime frameDescription
Postoperative complications12 monthsLesion recurred, minor trichiasis, partial sparse to absent eyelashes, hypertrophic scar, hyperpigmentation
Investigator's Global Assessment (IGA) score12 monthsInvestigator'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.
Patient satisfaction score12 monthsPatient 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.
Number of treatment sessions12 monthsNumber of treatment sessions for complete clearance

Countries

China

Contacts

Primary ContactDingqiao Wang, PhD
wangdingqiao@163.com13976031334

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026