CompletedNot Applicable

Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions

United States25 participantsStarted 2020-09-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. are of similar size (±50%),
✓. are between 16cm2 and 456cm2 (contiguous),
✓. are similarly sun exposed,
✓. have the same extent of leukotrichia, and
✓. are judged clinically as ≥90% depigmented (by area).

Exclusion criteria

✕. The study areas selected have concomitant dermatologic conditions other than vitiligo.
✕. The study area selected for treatment includes the lips, eyelids, plantar surface of feet, palmar surface of hands, fingertips, wrists, ankles, elbows, or knees.
✕. The patient is unable to undergo the treatment area preparation.
✕. Patients who are pregnant.
✕. Patients with:
✕. universalis vitiligo,
✕. depigmented areas over \>30% of their body surface area,
✕. depigmented lips and fingertips (lip-tip vitiligo), or

What they're measuring

Incidence of ≥80% Study Area Repigmentation

Timeframe: Week 24

Trial details

NCT IDNCT04547998

SponsorAvita Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-28

Results submitted2023-07-24

View on ClinicalTrials.gov More Vitiligo trials