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

• Sponsor: Avita Medical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05971381
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.3
• Patients Per Site Per Month: 8.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Device: RECELL® Autologous Cell Harvesting Device	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
• Anticipated Study Start Date: Jul 24, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Study Treatment Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.	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.; Other Names: Spray-On SkinTM Cells

Outcome Measures

Primary Outcome Measures

1. Repigmentation 26-50%, 51-79%, 80-99%, and 100%) [24 weeks post-treatment]

   Central Review Committee categorization of index area repigmentation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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.

2. The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has not satisfactorily responded to either:

3. topical therapy or

4. a minimum of 3 months of phototherapy.

5. The patient has a depigmented area available for treatment that is:

6. ≥90% depigmented,

7. without any other dermatologic conditions (other than vitiligo), and

8. excludes the lips, eyelids, plantar surface of feet, palmar surface of hands.

9. The patient is 18 years of age or older.

10. The patient agrees to remain on any current use of immunosuppressive therapy for the duration of his/her participation in the study (24 weeks).

11. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up study visits.

12. The patient agrees to abstain from any other treatment of the study area for the duration of his/her participation in the study (24 weeks).

13. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (24 weeks).

14. In the opinion of the investigator, the patient must be able to:

15. Understand the full nature and purpose of the study, including possible risks and benefits,

16. Understand instructions and be able to comprehend and complete study questionnaires, and

17. Provide voluntary written informed consent. -

Exclusion Criteria:

1. The patient is unable to undergo treatment area preparation.

2. Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009.

3. Patients with:

4. depigmented lips and fingertips (lip-tip vitiligo), or

5. depigmented areas over >30% of their body surface area.

6. Patients with recent history (within previous 12 months) of:

7. Koebnerization,

8. confetti-like, or

9. trichrome lesions.

10. Patients with a history of keloid formation.

11. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.

12. Current use of medications (e.g., anticoagulants such as heparin or warfarin) that in the investigator's opinion may compromise patient safety or trial objectives.

13. The patient has a known hypersensitivity to trypsin, compound sodium lactate for irrigation solution (Hartmann's solution), povidone-iodine, chlorhexidine, and/or lidocaine-containing anesthetics -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skin Care Research, LLC	Hollywood	Florida	United States	33021

Sponsors and Collaborators

• Avita Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Avita Medical
• ClinicalTrials.gov Identifier: NCT05971381
• Other Study ID Numbers: CTP010
• First Posted: Aug 2, 2023
• Last Update Posted: Aug 2, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Avita Medical: focal vitiligo; segmental vitiligo; nonsegmental vitiligo; generalized vitiligo
• Additional relevant MeSH terms: Vitiligo

Study Results

No Results Posted as of Aug 2, 2023