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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394349
• Other study ID #: 2023M-013
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: October 14, 2024

Study information

• Verified date: April 2024
• Source: Huashan Hospital
• Contact: Yijian Zhu, M.D.
• Phone: +8615921018163
• Email: jocelyn_zhu007[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Vitiligo is an acquired skin disorder characterized by depigmented macules, and one of the conventional treatment principles is to promote the differentiation of stem cells at the follicular bulge into melanocytes, but vitiligo of the extremities is clinically difficult to repigmentation and resistant to treatment due to its lack of hair follicles. Platelet-rich plasma (PRP) is a concentrated platelet plasma obtained by in vitro isolation of autologous whole blood, and its effect on repigmentation of vitiligo at the extremities and the potential mechanism remain unclear. The investigators investigated the efficacy of PRP on acral vitiligo by a single-center, prospective, self-controlled clinical study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 14, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Combination Product:
• PRP+308nm
PRP+308nm
• NS+308nm
NS+308nm

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Yijian Zhu

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. do — View Citation

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/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Average pigmentation value, average erythema value	They are observed and calculated by Antera 3D.	up to 24 weeks
Secondary	Pigment and erythema mode images	They are captured by Antera 3D.	up to 24 weeks
Secondary	Repigmentation patterns	They are observed by Antera 3D.	up to 24 weeks