Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions

Not Applicable

Completed

• Conditions: Vitiligo
• Interventions: Device: Control Intervention (UVB); Device: Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)

• Registration Number: NCT04547998
• Lead Sponsor: Avita Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study Start: 2020-09-10
• Study First Posted: 2020-09-14
• Primary Completion: 2022-06-28
• Study Completion: 2023-01-31
• Results First Submitted: 2023-07-24
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-25
• Results First Posted: 2023-09-21
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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, regardless of whether the areas are intended to be used as study areas.

1a. Photo documentation (current and at least 12 months prior) of the patient's depigmented areas have been evaluated as stable by an independent Screening Committee.

2. The patient has not undergone topical treatment (e.g., steroids, tacrolimus) for the study areas within the past 90 days.

3. The patient has not undergone phototherapy (e.g., NB-UVB) for the study areas within the past 90 days.

4. The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has previously been compliant with but has not satisfactorily responded to both

a. topical therapy and b. a minimum of 3 months of phototherapy.

5. The patient must have two study areas available for treatment that:

6. are of similar size (±50%),

7. are between 16cm2 and 456cm2 (contiguous),

8. are similarly sun exposed,

9. have the same extent of leukotrichia, and

10. are judged clinically as ≥90% depigmented (by area).

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

    7. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol.

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

    9. 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).

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

a. Understand the full nature and purpose of the study, including possible risks and adverse events, b. Understand instructions, and c. Provide voluntary written informed consent.

Exclusion Criteria

1. The study areas selected have concomitant dermatologic conditions other than vitiligo.

2. The study area selected for treatment includes the lips, eyelids, plantar surface of feet, palmar surface of hands, fingertips, wrists, ankles, elbows, or knees.

3. The patient is unable to undergo the treatment area preparation.

4. Patients who are pregnant.

5. Patients with:

   1. universalis vitiligo,
   2. depigmented areas over >30% of their body surface area,
   3. depigmented lips and fingertips (lip-tip vitiligo), or
   4. > 3 depigmented fingertips, defined as depigmentation of the dorsal aspect of the fingertip from the distal interphalangeal joint to the tip of the digit.

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

   1. Koebnerization,
   2. confetti-like, or
   3. trichrome lesions.

7. Patients with a history of keloid formation.

8. Patients who have used a tanning salon in the past 60 days.

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

10. 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.

11. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.

12. Life expectancy is less than 1 year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants (within patient control)	Control Intervention (UVB)	Each participant will serve as their own Control, receiving both Control and Investigational Interventions randomly allocated to treatment of a portion of a depigmented vitiligo lesion.
All Participants (within patient control)	Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)	Each participant will serve as their own Control, receiving both Control and Investigational Interventions randomly allocated to treatment of a portion of a depigmented vitiligo lesion.

Primary Outcome Measures

Name	Time	Method
Incidence of ≥80% Study Area Repigmentation	Week 24	Repigmentation was evaluated by qualified members of a Central Review Committee.

Secondary Outcome Measures

Name	Time	Method
Repigmentation Category	Week 24	Expert Central Review Committee categorization of the amount of area repigmented (0-25%, 26-50%, 51-79% and 80-100%). This is visual estimation of the vitiligo lesion area that has repigmented, with reference to training images. Higher %repigmentation is a better outcome.
Color Matching	Week 24	The Expert Central Review Committee visually judged the quality of repigmentation in terms of how closely it matches with the normal pigmentation seen in the surrounding area. The rating scale consists of poor, moderate, good, and excellent. Color matching can only be evaluated in instances of \>0% repigmentation.

Trial Locations

Locations (12)

Heights Dermatology; 🇺🇸 Houston, Texas, United States

Skin Care Research, LLC; 🇺🇸 Hollywood, Florida, United States

DMR Research; 🇺🇸 Westport, Connecticut, United States

Miami Dermatology and Laser Institute; 🇺🇸 Miami, Florida, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

Dermatology, Laser & Vein Specialists of the Carolinas; 🇺🇸 Charlotte, North Carolina, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

West Dermatology; 🇺🇸 San Diego, California, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Texas at Austin Dell Medical School; 🇺🇸 Austin, Texas, United States