NCT05053022

A Study to Evaluate the Efficacy of Microneedling as a Stand-alone Treatment for Vitiligo

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Crown Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a study that is being conducted in order to assess the efficacy of microneedling as a stand-alone treatment for vitiligo. Vitiligo is an autoimmune depigmentation disease of the skin that is characterized by the destruction of epidermal melanocytes by CD8+ T cells. The pathogenesis of Vitiligo has been linked to autoimmunity, oxidative stress, and genetic susceptibility.

Detailed description

Microneedling is a minimally invasive technique developed for skin rejuvenation. In the treatment for vitiligo, the procedure causes micro-inflammations on the epidermis and enhances melanocytes and keratinocytes migration. This process leads to the stimulation and repigmentation of vitiligo areas. Several topical therapies such as Tacrolimus and 5-Fluorouracilused in conjunction with microneedling have yielded favorable repigmentation results. This study aims to evaluate the repigmentation rates of microneedled vitiligo patches without any topical medications other than sunscreen. There will be a total of 8 -12 treatments over the course of 244 days, with subjects receiving a treatment every 2 weeks.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DEVICE	Skinpen Precision System	Subjects will receive a total of 8-12 treatments with the Skinpen Precision system targeting their Vitiligo lesions.

Timeline

• Start date: 2021-07-29
• Primary completion: 2022-11-21
• Completion: 2023-01-24
• First posted: 2021-09-22
• Last updated: 2023-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study