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

NCT06394349 | Recruiting

• 1 other identifier: 2023M-013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vitiligo

Keywords

Acral vitiligo; Platelet-rich plasma; 308 nm excimer light

Outcome Measures

Primary Outcomes (3)

• VASI (vitiligo area severity index) score

  The calculation of VASI (vitiligo area severity index) scores was performed by analysing standard photographs taken in the clinic at each specified follow-up time. The range is 0-100 and lower scores mean a better outcome.

  up to 24 weeks

• VASI improvement

  VASI improvement rate = (VASI baseline - VASI follow-up) / VASI baseline × 100 %. The range is 0-100% and higher index means a better outcome.

  up to 24 weeks

• Side effect questionnaire and Dermatology Life Quality Index (DLQI)

  The side effect questionnaire includes discomfort such as pain, itching, erythema, or allergic reactions. The dermatology life quality index (DLQI) range is 0-30 and higher scores mean a better outcome.

  up to 24 weeks

Secondary Outcomes (3)

• Average pigmentation value, average erythema value

  up to 24 weeks

• Pigment and erythema mode images

  up to 24 weeks

• Repigmentation patterns

  up to 24 weeks

Study Arms (2)

PRP+308nm

EXPERIMENTAL

The observation group received PRP intradermal injections (0.5cm apart, 0.02ml injected) once a month and 308 nm excimer phototherapy twice a week for 6 consecutive months.

Combination Product: PRP+308nm

NS+308nm

PLACEBO COMPARATOR

The control group received the same frequency of saline injections (0.5cm apart, 0.02ml injected) and phototherapy for 6 consecutive months.

Combination Product: NS+308nm

Interventions

PRP+308nm COMBINATION_PRODUCT

PRP+308nm

PRP+308nm

NS+308nm COMBINATION_PRODUCT

NS+308nm

NS+308nm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yijian Zhu: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (3)

• Elsaadany AE, El-Khalawany M, Elshahid AR, Seddeik Abdel-Hameed AK. Comparison between 308-nm excimer light alone versus 308-nm excimer light and platelet-rich plasma in the treatment for localized vitiligo. J Cosmet Dermatol. 2022 Jul;21(7):2826-2831. doi: 10.1111/jocd.14582. Epub 2021 Oct 31.

  PMID: 34719101 RESULT

• Deng Y, Li J, Yang G. 308-nm Excimer Laser Plus Platelet-Rich Plasma for Treatment of Stable Vitiligo: A Prospective, Randomized Case-Control Study. Clin Cosmet Investig Dermatol. 2020 Jul 23;13:461-467. doi: 10.2147/CCID.S260434. eCollection 2020.

  PMID: 32801821 RESULT

• Ibrahim ZA, El-Ashmawy AA, El-Tatawy RA, Sallam FA. The effect of platelet-rich plasma on the outcome of short-term narrowband-ultraviolet B phototherapy in the treatment of vitiligo: a pilot study. J Cosmet Dermatol. 2016 Jun;15(2):108-16. doi: 10.1111/jocd.12194. Epub 2015 Dec 23.

  PMID: 26695436 RESULT

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yijian Zhu, M.D.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yijian Zhu, M.D.

CONTACT

+8615921018163; jocelyn_zhu007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 1, 2024
• Study Start: February 22, 2023
• Primary Completion: August 30, 2024
• Study Completion: October 14, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)