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

Vitiligo Clinical Trial

— TONE  

Official title:

The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05971381
• Other study ID #: CTP010
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Avita Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. topical therapy or

2. a minimum of 3 months of phototherapy.

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

1. =90% depigmented,

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

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

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

5. The patient agrees to remain on any current use of immunosuppressive therapy for the duration of his/her participation in the study (52 weeks).

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

7. The patient agrees to abstain from any other treatment of the study area for the duration of his/her participation in the study (52 weeks).

8. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (52 weeks).

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

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

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

3. 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:

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

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

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

1. Koebnerization,

2. confetti-like, or

3. trichrome lesions.

5. Patients with a history of keloid formation.

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

7. 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.

8. 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 -

Related Conditions & MeSH terms

• Vitiligo

Intervention

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.

Locations

Country	Name	City	State
United States	Siperstein Dermatology Group	Boynton Beach	Florida
United States	Hamzavi Dermatology	Canton	Michigan
United States	Clarity Dermatology	Castle Rock	Colorado
United States	Dermatology, Laser and Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Dermatologic Surgery Center of Washington	Chevy Chase	Maryland
United States	Henry Ford Health	Detroit	Michigan
United States	Skin Care Research, LLC	Hollywood	Florida
United States	Maryland Laser, Skin & Vein Institute	Hunt Valley	Maryland
United States	University of California, Irvine	Irvine	California
United States	Mount Sinai	New York	New York
United States	The Dermatology Specialist	New York	New York
United States	West Dermatology Research Center	San Diego	California
United States	Affiliated Dermatology	Scottsdale	Arizona
United States	Sutter Health	Sunnyvale	California
United States	California Dermatology Institute	Thousand Oaks	California
United States	Grekin Skin Institute	Warren	Michigan
United States	University Of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Avita Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)	Central Review Committee categorization of index area repigmentation	24 weeks post-treatment