Eyelid TumorNCT06206681
Efficacy and Safety of Ultrapulse Carbon Dioxide Laser Treatment in Eyelid Tumors
An observational study of Eyelid Tumor and Xanthelasma Palpebrarum, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eyelid Tumor, Xanthelasma Palpebrarum, Pigmented Nevi
- What is being tested?
- Ultra-pulsed Carbon Dioxide Laser
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of 1000 patients with eyelid tumors, including various types of tumors. Inclusive of xanthelasma, pigmented nevi, keratoses, and so on.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guanzhou
Xianchai Lin, Doctor, 13922244056, linxch7@mail.sysu.edu.cn
About this study
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.
Read the 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
- Conditions
- Eyelid Tumor, Xanthelasma Palpebrarum, Pigmented Nevi, Keratosis
- Being tested
- Ultra-pulsed Carbon Dioxide Laser
- Medical subject headings
- Eyelid Neoplasms, Xanthomatosis, Nevus, Pigmented, Keratosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-pulsed Carbon Dioxide LaserProcedure or surgery
Also called CO2 Laser
Excision of eyelid lesion
| Study group | Role | What they receive |
|---|---|---|
| Ultrapulse 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. Receives: Procedure: Ultra-pulsed Carbon Dioxide Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance rate
The lesion clearance rate was classified as the proportion of the lesion cleared (<50%; 50-75%; 76-99%; or >99%).
Measured: 12 months
Recurrence rate
Recurrence was defined as the regrowth of a new xanthelasma lesion within the previously excised area.
Measured: 12 months
Secondary outcomes (4)
Postoperative complications
Lesion recurred, minor trichiasis, partial sparse to absent eyelashes, hypertrophic scar, hyperpigmentation
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Number of treatment sessions
Number of treatment sessions for complete clearance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Nov 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
- Investigators
- Xianchai Lin, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206681
- Sponsor's protocol ID
- 2023KYPJ286
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ultrapulse Carbon Dioxide Laser Treatment in Eyelid Tumors
- ClinicalTrials.gov ID
- NCT06206681
- Acronym / sponsor ID
- 2023KYPJ286
- Conditions
- Eyelid Tumor, Xanthelasma Palpebrarum, Pigmented Nevi, Keratosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrapulse Carbon Dioxide Laser | – | Procedure: Ultra-pulsed Carbon Dioxide LaserThe study investigates the use of the Ultrapulse Carbon Dioxide Laser for the excision of eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 1000 patients with eyelid tumors, including various types of tumors. Inclusive of xanthelasma, pigmented nevi, keratoses, and so on.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-pulsed Carbon Dioxide LaserAlso: CO2 LaserExcision of eyelid lesion | Procedure or surgery | Ultrapulse Carbon Dioxide Laser |
Primary outcome
Clearance rate
Time frame: 12 months
The lesion clearance rate was classified as the proportion of the lesion cleared (<50%; 50-75%; 76-99%; or >99%).
Recurrence rate
Time frame: 12 months
Recurrence was defined as the regrowth of a new xanthelasma lesion within the previously excised area.
4 secondary outcomes
Postoperative complications
Time frame: 12 months
Investigator's Global Assessment (IGA) score
Time frame: 12 months
Patient satisfaction score
Time frame: 12 months
Number of treatment sessions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianchai Lin, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eyelid Tumor and Xanthelasma Palpebrarum, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dingqiao Wang, PhD (13976031334, wangdingqiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.