Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394349
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-24
Brief Title:
Platelet-rich Plasma Intradermal Injection Combined With 308 nm Excimer Light for Treating Stable Acral Vitiligo
Sponsor:
Yijian Zhu
Organization:
Huashan Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None