Clinical trial NCT06869291: Observation of the Effect and Mechanism of Multi Tunnel Minimally Invasive Treatment for Xanthelasma Palpebrarum
Official title: Observation of the Effect and Mechanism of Multi Tunnel Minimally Invasive Treatment for Xanthelasma Palpebrarum
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Xanthelasma Palpebrarum
Keywords: Xanthelasma Palpebrarum
Lead sponsor: Fuzhou First General Hospital Skin Disease Prevention and Control Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Heparin Sodium Injection Procedure:

1. Disinfect the XP and the area 1cm beyond the lesion margin three times using iodophor and cotton swabs.
2. Dilute heparin sodium with 0.9% saline to a concentration of 2500 - 5000 U/ml, preparing 0.1ml of liquid per 1cm² of lesion area.
3. Use a 1ml syringe to insert the needle near the edge of the lesion, the puncture site should preferably be close to the eyebrow, ensuring that the gauze cover post-injection does not obstruct the view.
4. The needle should reach the space between the epidermis and dermis layers, creating an "orange-peel appearance" post-injection, fully covering the lesion area.
5. Cover the injection site with gauze for 6-8 hours.
6. The treatment should be repeated every 5-14 days.

Autologous Blood Injection and Autologous Blood + Heparin Sodium Injection Procedure:

1. Draw blood from the patient's arm vein, preparing 0.1ml of liquid per 1cm² of lesion area.
2. Disinfect the XP and the area 1cm beyond the lesion margin three times using iodophor and cotton swabs.
3. Dilute heparin sodium with 0.9% saline/autologous blood to a concentration of 2500 - 5000 U/ml, preparing 0.1ml of liquid per 1cm² of lesion area.
4. Insert the needle from the edge of the lesion near the eyebrow using a 1ml syringe, ensuring that the gauze cover post-injection does not obstruct the field of view.
5. The needle should reach the space between the epidermis and dermis layers, creating an "orange-peel appearance" post-injection, fully covering the lesion area.
6. Cover the injection site with gauze for 6-8 hours.
7. The treatment should be repeated every 5-14 days (The next treatment can commence once the hematoma has completely resolved ).

Multi-Level Multi-Tunnel Puncture(MMP) and Multi-Level Multi-Tunnel Puncture(MMP) + Heparin Sodium Injection Procedure:

1. Disinfect the XP and the area 1cm beyond the lesion margin three times using iodophor and cotton swabs.
2. Use a 1ml syringe to inject lidocaine for local anesthesia in the XP lesion area.
3. Dilute heparin sodium with 0.9% saline to a concentration of 2500 - 5000 units/ml, preparing 0.1ml of liquid per 1cm² of lesion area (omit this step if using MMP treatment alone).
4. Use a 1ml syringe to insert the needle near the eyebrow edge of the lesion, ensuring that the gauze cover post-injection does not obstruct the view (omit this step if using MMP treatment alone).
5. The needle should reach the space between the epidermis and dermis layers, creating an "orange-peel appearance" post-injection , fully covering the lesion area (omit this step if using MMP treatment alone).
6. Use a 1ml syringe to puncture between the epidermis and dermis, within the papillary and reticular layers, with the puncture endpoint at the lesion margin. Avoid penetrating the skin completely and try to leave only one needle hole upon withdrawal. The distance between adjacent tunnel endpoints within the same layer should be 1mm; stagger the tunnels in adjacent layers .
7. Cover the injection site with gauze for 6-8 hours.
8. The treatment should be repeated every 7-14 days (The next treatment can commence once the hematoma has completely resolved ).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Hemophilia
* Coronary heart disease
* Myocardial infarction
* Cerebral infarction

Primary outcomes:
measure: Proportion of regression area of xanthelasma palpebrarum
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: No. 243 Xihong Road, Gulou District, Fuzhou City, Fujian Province
state: Fujian
Study officials:
References: