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

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

Study Overview

• Status: Recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Combination product: PRP+308nm; Combination product: NS+308nm

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yijian Zhu, M.D.; Phone Number: +8615921018163; Email: jocelyn_zhu007@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital
      • Contact: Yijian Zhu, M.D.; Phone Number: +8615921018163; Email: jocelyn_zhu007@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP+308nm; 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; PRP+308nm
Placebo Comparator: NS+308nm; 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; NS+308nm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average pigmentation value, average erythema value	They are observed and calculated by Antera 3D.	up to 24 weeks
Pigment and erythema mode images	They are captured by Antera 3D.	up to 24 weeks
Repigmentation patterns	They are observed by Antera 3D.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Yijian Zhu
• Investigators: Principal Investigator: Yijian Zhu, M.D., Huashan Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): October 14, 2024

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Platelet-rich plasma; Acral vitiligo; 308 nm excimer light
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: 2023M-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No