This is a prospective blinded within-subject randomized study to evaluate the application of Spray-On Skin™ Cells, prepared using the RECELL® Device for safe and effective repigmentation of ablated stable vitiligo lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Targeted narrowband-UVB phototherapy in alignment with published Vitiligo Working Group recommendations.
Spray-On Skin™ Cells prepared using RECELL will be applied to an area prepared by ablative laser, followed by targeted narrowband UVB phototherapy.
University of California, Irvine
Irvine, California, United States
University of California, Davis
Sacramento, California, United States
West Dermatology
San Diego, California, United States
Incidence of ≥80% Study Area Repigmentation
Repigmentation was evaluated by qualified members of a Central Review Committee.
Time frame: Week 24
Repigmentation Category
Expert Central Review Committee categorization of the amount of area repigmented (0-25%, 26-50%, 51-79% and 80-100%). This is visual estimation of the vitiligo lesion area that has repigmented, with reference to training images. Higher %repigmentation is a better outcome.
Time frame: Week 24
Color Matching
The Expert Central Review Committee visually judged the quality of repigmentation in terms of how closely it matches with the normal pigmentation seen in the surrounding area. The rating scale consists of poor, moderate, good, and excellent. Color matching can only be evaluated in instances of \>0% repigmentation.
Time frame: Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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