Clinical trial NCT04547998: Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
Official title: A Prospective Blinded Within-Subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Lead sponsor: Avita Medical
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

1. are of similar size (±50%),
2. are between 16cm2 and 456cm2 (contiguous),
3. are similarly sun exposed,
4. have the same extent of leukotrichia, and
5. 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.

Primary outcomes:
measure: Incidence of ≥80% Study Area Repigmentation
timeFrame: Week 24
Secondary outcomes:
measure: Repigmentation Category
timeFrame: Week 24
measure: Color Matching
timeFrame: Week 24
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Diego
country: United States
facility: West Dermatology
state: California
city: Westport
country: United States
facility: DMR Research
state: Connecticut
city: Hollywood
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Institute
state: Florida
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: University of Texas at Austin Dell Medical School
state: Texas
city: Houston
country: United States
facility: Heights Dermatology
state: Texas
Study officials:
References:
citation: Liu JP, Hsueh HM, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med. 2002 Jan 30;21(2):231-45. doi: 10.1002/sim.1012.