Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Anand Ganesan, MD

Description

Summary

This is a Prospective Multi-Arm Blinded Evaluator 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.

Official Title

A Prospective Multi-Arm Blinded Evaluator Within-Subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions

Keywords

Vitiligo Spray-On Skin™ Cells 1:5 with NB-UVB Spray-On Skin™ Cells 1:10 with NB-UVB Spray-On Skin™ Cells 1:20 with NB-UVB NB-UVB only

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Focal, segmental or generalized (i.e., nonsegmental) vitiligo photographically documented as stable (no new lesions nor lesions expanding in size within the preceding 12 months, regardless of whether the lesions are intended for treatment/control in this study).
  2. The patient has not undergone topical treatment (e.g., steroids) for the study lesion within the past 60 days.
  3. The patient has not undergone phototherapy (e.g., NB-UVB) for the study lesion within the past 6 months.
  4. The patient is a candidate for surgical intervention for treatment of a depigmented area, defined as: the patient has been compliant but has not satisfactorily responded to topical therapy and a minimum of 3 months of phototherapy.
  5. Two separate areas of the same size (±10%) available for treatment within the depigmented study lesion.
  6. The two study areas must both be similarly sun exposed.
  7. The extent of leukotrichia must be similar between the two study areas.
  8. The two study areas each have a minimum area of 16 cm2
  9. The patient is 18 years of age or older.
  10. . The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol.
  11. . 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).
  12. . 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).
  13. . In the opinion of the investigator, the patient must be able to:
  14. Understand the full nature and purpose of the study, including possible risks and adverse events,
  15. Understand instructions, and
  16. Provide voluntary written informed consent

You CAN'T join if...

  1. The area requiring treatment is not associated with vitiligo.
  2. Study areas include the lips, eyelids, distal phalanges, plantar surface of feet, palmar surface of hands, wrists, ankles, elbows, or knees.
  3. The patient is unable to undergo the treatment area preparation.
  4. Patients who are pregnant.
  5. Patients with universalis vitiligo, depigmented areas over >30% of their body surface area, or depigmented fingertips.
  6. Patients with recent history within 12 months of Koebnerization, confetti-like or 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

Locations

  • University of California, Irvine not yet accepting patients
    Irvine California 92697 United States
  • AboutSkin Dermatology accepting new patients
    Greenwood Village Colorado 80111 United States

Lead Scientist at UC Irvine

  • Anand Ganesan, MD
    Professor, Dermatology. Authored (or co-authored) 29 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avita Medical
ID
NCT04547998
Study Type
Interventional
Last Updated