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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Enrollment
5
Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
University of Massachusetts
Worcester, Massachusetts, United States
Repigmentation
Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator
Time frame: 24 weeks
Categorization of Repigmentation
Categorization of each study area in terms of ranges of percent repigmentation by a Blinded Evaluator (0-25%, 26-50%, 51-79%, 80-100%)
Time frame: 4, 12 and 24 weeks
Responders
Proportion of treated lesions achieving ≥80% or \<80% repigmentation as assessed by a Blinded Evaluator.
Time frame: 24 weeks
Subject Repigmentation Rating
Ratings of poor, moderate, good, or excellent
Time frame: 4, 12 and 24 weeks
Blinded Evaluator Color Matching
Assessment of color matching (0-3: poor, moderate, good, excellent) inclusive of hypopigmentation and hyperpigmentation
Time frame: 4, 12 and 24 weeks
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Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation