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

NCT04271501 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-03-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Avita Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2021-08-24
Completion
2021-08-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271501 on ClinicalTrials.gov