CompletedNot Applicable

Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells

United States109 participantsStarted 2023-08-14

Plain-language summary

To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Focal, segmental, or generalized (i.e., nonsegmental) stable vitiligo, defined as no new depigmented areas nor any depigmented areas that have expanded in size within the preceding 12 months.
✓. The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has not satisfactorily responded to either:
✓. topical therapy or
✓. a minimum of 3 months of phototherapy.
✓. The patient has a depigmented area available for treatment that is:
✓. ≥90% depigmented,
✓. without any other dermatologic conditions (other than vitiligo), and
✓. excludes the lips, eyelids, plantar surface of feet, palmar surface of hands.

✕. The patient is unable to undergo treatment area preparation.
✕. Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009.
✕. Patients with:
✕. depigmented lips and fingertips (lip-tip vitiligo), or
✕. depigmented areas over \>30% of their body surface area.
✕. Patients with recent history (within previous 12 months) of:
✕. Koebnerization,
✕. confetti-like, or

Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)

Timeframe: 24 weeks post-treatment

NCT IDNCT05971381

SponsorAvita Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-30