Trials / Completed
CompletedNCT05971381
Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Avita Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device.
Detailed description
Prospective, multicenter single-arm pre-/post interventional study to evaluate the clinical performance of RECELL for repigmentation of stable depigmented lesions.Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy. Repigmentation of treatment areas will be determined via centralized image interpretation by an expert dermatological panel (i.e., Central Review Committee, CRC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RECELL® Autologous Cell Harvesting Device | The RECELL Device is for use at the patient's point-of-care for the safe and rapid preparation of Spray-On SkinTM Cells from a small sample of a patient's own skin. |
Timeline
- Start date
- 2023-08-14
- Primary completion
- 2024-07-30
- Completion
- 2025-01-31
- First posted
- 2023-08-02
- Last updated
- 2025-02-06
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05971381. Inclusion in this directory is not an endorsement.