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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP+308nm | Combination Product | PRP+308nm |
| |
| NS+308nm |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yijian Zhu, M.D. | Contact | +8615921018163 | jocelyn_zhu007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yijian Zhu, M.D. | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34719101 | Result | 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. | |
| 32801821 | Result |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Combination Product |
NS+308nm |
|
| up to 24 weeks |
| Repigmentation patterns | They are observed by Antera 3D. | up to 24 weeks |
| 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. |
| 26695436 | 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. |