RecruitingNot ApplicableNCT06394349

Platelet-rich Plasma Intradermal Injection Combined With 308 nm Excimer Light for Treating Stable Acral Vitiligo

Platelet-rich Plasma Intradermal Injection in Addition to 308 nm Excimer Light in the Treatment of Stable Acral Vitiligo: A Prospective Randomized Placebo-controlled Study


Sponsor

Yijian Zhu

Enrollment

20 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if platelet-rich plasma (PRP) works to treat acral stable vitiligo in adults. It will also learn about the safety of platelet-rich plasma. The main questions it aims to answer are: * Does PRP combined with 308 nm excimer phototherapy improve the efficacy compared to 308 nm excimer light alone in the treatment of vitiligo of the extremities? * What medical problems do participants have when taking PRP intradermal injections? Researchers will compare PRP to a placebo (a look-alike substance that contains no drug) to see if PRP works to treat acral vitiligo. Participants will: * Receive PRP intradermal injections once a month and 308 nm excimer phototherapy twice a week, or the same frequency of saline injections and phototherapy for 6 consecutive months * Visit the clinic once every 1 month for evaluations * Keep a diary of their symptoms or side effects during follow-up


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • Patients with non-segmental vitiligo stable for more than half a year;
  • At least 1 separate stable lesion on each of the dorsum of the right and left hands, proximal fingers, distal fingers and palms;
  • The area of white spots is less than 10 % of the total body surface area and more than 1 % of the total body surface area;
  • Those who have not received systemic treatment of vitiligo and phototherapy or related treatments within 1 month ≥ 1 year without significant efficacy;
  • Voluntary signing of informed consent.

Exclusion Criteria9

  • Pregnant and lactating women;
  • Those who have used glucocorticoids or other immunosuppressants in the last 3 months;
  • Suffering from haematological disorders such as coagulation abnormalities and thrombocytopoietic disorders;
  • Those who are allergic to ultraviolet light and photosensitive treatment;
  • Scar constitution;
  • Those with current or previous history of skin cancer or family history of skin cancer;
  • Those with infectious diseases such as HIV, syphilis, hepatitis B or C;
  • Those with other serious systemic diseases;
  • Patients who, in the judgement of the investigator, are not suitable for inclusion in this trial.

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Interventions

COMBINATION_PRODUCTPRP+308nm

PRP+308nm

COMBINATION_PRODUCTNS+308nm

NS+308nm


Locations(1)

Huashan Hospital

Shanghai, Shanghai Municipality, China

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NCT06394349


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