NCT04271501

Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions

A Prospective Blinded Randomized Within-Subject Controlled Clinical Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure (MKTP) for Repigmentation of Stable Vitiligo Lesions

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Avita Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Prospective randomized within-subject controlled feasibility study to evaluate the clinical performance of RECELL for repigmentation of stable, depigmented lesions. The trial will evaluate 50 matched, stable depigmented areas from 10 subjects.

Conditions

• Vitiligo

Interventions

Type	Name	Description
PROCEDURE	Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)	Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas
DEVICE	RECELL 1:5 and Ultraviolet Lamp (UVB)	Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
DEVICE	RECELL 1:10 and Ultraviolet Lamp (UVB)	Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
DEVICE	RECELL 1:20 and Ultraviolet Lamp (UVB)	Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation

Timeline

• Start date: 2020-09-25
• Primary completion: 2021-08-24
• Completion: 2021-08-24
• First posted: 2020-02-17
• Last updated: 2023-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study