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Xanthelasma PalpebrarumNCT06869291

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

A study testing Multi level and multi tunnel puncture treatment, Heparin Sodium Injection and Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection in people with Xanthelasma Palpebrarum, run by Fuzhou First General Hospital Skin Disease Prevention and Control Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Xanthelasma Palpebrarum
What is being tested?
Multi level and multi tunnel puncture treatment, Heparin Sodium Injection and Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteChina
Study dates
1 Feb 2025to 1 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • No. 243 Xihong Road, Gulou District, Fuzhou City, Fujian Province

    Fuzhou, Fujian, 350004

Other trials in China

About this study

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".

Read more

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.

Read the 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 ).
Being tested
Multi level and multi tunnel puncture treatment, Heparin Sodium Injection, Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection
Keywords
Xanthelasma Palpebrarum
Medical subject headings
Xanthomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi level and multi tunnel puncture treatmentProcedure or surgery

    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.
  • Heparin Sodium InjectionProcedure or surgery

    (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.

  • Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium InjectionProcedure or surgery

    (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.

Study groups in NCT06869291
Study groupRoleWhat they receive
Heparin Sodium InjectionActive comparator1. 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.
Receives: Procedure: Heparin Sodium Injection
Multi Level and Multi Tunnel Puncture TreatmentExperimental1. 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.
Receives: Procedure: Multi level and multi tunnel puncture treatment
Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium InjectionExperimental1. 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.
Receives: Procedure: Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of regression area of xanthelasma palpebrarum

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start1 Feb 2025
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06869291
Sponsor's protocol ID
FZSPFY
Status last verified
Feb 2025
First submitted
26 Feb 2025
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multi level and multi tunnel puncture treatment, Heparin Sodium Injection and Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection in people with Xanthelasma Palpebrarum, run by Fuzhou First General Hospital Skin Disease Prevention and Control Hospital 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 11 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of regression area of xanthelasma palpebrarum (time frame: From enrollment to the end of treatment at 12 weeks). 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 11 Mar 2025.

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