Observation of the Effect and Mechanism of Multi Tunnel Minimally Invasive Treatment for Xanthelasma Palpebrarum

NCT06869291 | Enrolling By Invitation DMC

• 1 other identifier: FZSPFY
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Dear research participants: Participants will be invited to participate in a research project led by the Dermatology Prevention and Treatment Institute of Fuzhou First General Hospital (Huang Zhiyong) (15260471946). The research project is titled "New Directions in the Treatment of Xanthelasma Palpebrarum: Research on Hematoma Related Treatment Methods and Mechanisms". Participants' participation in this study is voluntary, and this informed consent form provides participants with some information to help participants decide whether to participate in this clinical study. This study has been reviewed and approved by the Ethics Committee of the Dermatology Prevention and Treatment Hospital of Fuzhou First General Hospital. The Ethics Committee office phone number is 0591-83787173. If participants agree to join this study, please read it carefully and if participants have any questions, please raise them with the researcher responsible for the study. Research objective: Exploring whether multi tunnel minimally invasive treatment and heparin induced hematoma can initiate immune response through DAMP, mediate Toll like receptor activation of Th2 cells, secrete IL-4 and IL-13 to activate neutrophils and M2 macrophages, and then engulf cholesterol, triglycerides, and apolipoprotein in xanthelasma palpebrarum, ultimately leading to its disappearance.

Conditions

Xanthelasma Palpebrarum

Keywords

Xanthelasma Palpebrarum

Outcome Measures

Primary Outcomes (1)

• Proportion of regression area of xanthelasma palpebrarum

  From enrollment to the end of treatment at 12 weeks

Study Arms (3)

Heparin Sodium Injection

ACTIVE COMPARATOR

1. Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; 2. Prepare heparin sodium and lidocaine in ratios of 1:1, and prepare 0.1ml of liquid per 1cm2 of lesion area; 3. Use a 1ml syringe to insert the needle from the edge of the lesion near the eyebrow, so that it will not cover the field of view with gauze after injection; 4. The injection depth is the gap between the epidermal layer and the dermis layer, forming an "orange peel appearance" after injection, and completely covering the lesion area; 5. Cover the injection site with gauze and maintain for 6-8 hours.

Procedure: Heparin Sodium Injection

Multi Level and Multi Tunnel Puncture Treatment

EXPERIMENTAL

1. Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; 2. Use a 1ml syringe to extract lidocaine for local anesthesia of the eyelid xanthoma lesion area; 3. Use a 1ml syringe to puncture the area between the epidermis and dermis layers, nipple layer, and reticular layer of the lesion, with the puncture endpoint at the edge of the lesion. Be careful not to penetrate the skin as much as possible, and when withdrawing the syringe, do not let the needle completely leave the puncture hole, leaving only one pinhole as much as possible; Within the same level, the distance between adjacent puncture tunnel ends is 1mm; Arrange the puncture tunnels staggered within adjacent levels; 4. Cover the injection site with gauze and maintain for 6-8 hours.

Procedure: Multi level and multi tunnel puncture treatment

Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection

EXPERIMENTAL

1. Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; 2. Prepare heparin sodium and lidocaine in ratios of 1:1, and prepare 0.1ml of liquid per 1cm2 of lesion area; 3. Use a 1ml syringe to extract lidocaine for local anesthesia of the eyelid xanthoma lesion area; 4. Use a 1ml syringe to puncture the area between the epidermis and dermis layers, nipple layer, and reticular layer of the lesion, with the puncture endpoint at the edge of the lesion. Be careful not to penetrate the skin as much as possible, and when withdrawing the syringe, do not let the needle completely leave the puncture hole, leaving only one pinhole as much as possible; Within the same level, the distance between adjacent puncture tunnel ends is 1mm; Arrange the puncture tunnels staggered within adjacent levels; 5. Cover the injection site with gauze and maintain for 6-8 hours.

Procedure: Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection

Interventions

Multi level and multi tunnel puncture treatment PROCEDURE

Multi level and multi tunnel puncture treatment steps 1. Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; 2. Use a 1ml syringe to extract lidocaine for local anesthesia of the eyelid xanthoma lesion area; 3. Use a 1ml syringe to puncture the area between the epidermis and dermis layers, nipple layer, and reticular layer of the lesion, with the puncture endpoint at the edge of the lesion. Be careful not to penetrate the skin as much as possible, and when withdrawing the syringe, do not let the needle completely leave the puncture hole, leaving only one pinhole as much as possible; Within the same level, the distance between adjacent puncture tunnel ends is 1mm; Arrange the puncture tunnels staggered within adjacent levels; 4. Cover the injection site with gauze and maintain for 6-8 hours.

Multi Level and Multi Tunnel Puncture Treatment

Heparin Sodium Injection PROCEDURE

(1) Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; (2) Prepare heparin sodium and lidocaine in ratios of 1:1, and prepare 0.1ml of liquid per 1cm2 of lesion area; (3) Use a 1ml syringe to insert the needle from the edge of the lesion near the eyebrow, so that it will not cover the field of view with gauze after injection; (4) The injection depth is the gap between the epidermal layer and the dermis layer, forming an "orange peel appearance" after injection, and completely covering the lesion area; (5) Cover the injection site with gauze and maintain for 6-8 hours.

Heparin Sodium Injection

Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection PROCEDURE

(1) Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; (2) Prepare heparin sodium and lidocaine in ratios of 1:1, and prepare 0.1ml of liquid per 1cm2 of lesion area; (3) Use a 1ml syringe to extract lidocaine for local anesthesia of the eyelid xanthoma lesion area; (4) Use a 1ml syringe to puncture the area between the epidermis and dermis layers, nipple layer, and reticular layer of the lesion, with the puncture endpoint at the edge of the lesion. Be careful not to penetrate the skin as much as possible, and when withdrawing the syringe, do not let the needle completely leave the puncture hole, leaving only one pinhole as much as possible; Within the same level, the distance between adjacent puncture tunnel ends is 1mm; Arrange the puncture tunnels staggered within adjacent levels; (5) Cover the injection site with gauze and maintain for 6-8 hours.

Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of xanthelasma palpebrarum
• Must be able to receive heparin sodium injection and multi tunnel minimally invasive treatment

You may not qualify if:

• Hemophilia
• Coronary heart disease
• Myocardial infarction
• Cerebral infarction

Sponsors & Collaborators

• Fuzhou First General Hospital Skin Disease Prevention and Control Hospital: lead

Study Sites (1)

No. 243 Xihong Road, Gulou District, Fuzhou City, Fujian Province

Fuzhou, Fujian, 350004, China

Location

MeSH Terms

Conditions

Xanthomatosis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 11, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)