Trials / Completed
CompletedNCT04547998
Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
A Prospective Blinded Within-Subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Avita Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Control Intervention (UVB) | Targeted narrowband-UVB phototherapy in alignment with published Vitiligo Working Group recommendations. |
| DEVICE | Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB) | Spray-On Skin™ Cells prepared using RECELL will be applied to an area prepared by ablative laser, followed by targeted narrowband UVB phototherapy. |
Timeline
- Start date
- 2020-09-10
- Primary completion
- 2022-06-28
- Completion
- 2023-01-31
- First posted
- 2020-09-14
- Last updated
- 2024-05-24
- Results posted
- 2023-09-21
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04547998. Inclusion in this directory is not an endorsement.