Vitiligo
Conditions
Keywords
Vitiligo
Brief summary
Prospective randomized within-subject controlled feasibility study to evaluate the clinical performance of RECELL for repigmentation of stable, depigmented lesions. The trial will evaluate 50 matched, stable depigmented areas from 10 subjects.
Interventions
PROCEDUREMelanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)
Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas
DEVICERECELL 1:5 and Ultraviolet Lamp (UVB)
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
DEVICERECELL 1:10 and Ultraviolet Lamp (UVB)
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
DEVICERECELL 1:20 and Ultraviolet Lamp (UVB)
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
Sponsors
Avita Medical
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Repigmentation will be evaluated via measurement of the area repigmented and will be rated by the patient and a Blinded Evaluator (blinded to treatment allocation) using standardized photographs.
Intervention model description
Each subject serves as their own control.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria to be eligible: 1. Focal, segmental or generalized (i.e., nonsegmental) vitiligo 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 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. Five discrete 3cm by 3cm areas are available for treatment within the depigmented lesion. 6. The 5 study areas must be similarly sun exposed. 7. The extent of leukotrichia must be similar between the five study areas. 8. The patient is ≥ 22 years of age. 9. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol. 10. The patient agrees to abstain from any other treatment of the study areas for the duration of the his/her participation in the study (24 weeks). 11. 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). 12. In the opinion of the investigator, the patient and/or guardian must be able to: 1. Understand the full nature and purpose of the study, including possible risks and adverse events, 2. Understand instructions, and 3. Provide voluntary written informed consent.
Exclusion criteria
Subjects who meet any of the following criteria are not eligible: 1. The area requiring treatment is not associated with vitiligo. 2. Study areas contain the distal phalanges. 3. The patient in 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 lips and fingertips (lip-tip vitiligo). 6. Patient with a history of keloid formation. 7. Patients who have used a tanning salon in the past 60 days. 8. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. 9. Current use of medications (e.g., anticoagulants such as such as heparin or warfarin) that in the investigator's opinion may compromise patient safety or trial objectives. 10. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution. 11. The patient has recent history (within 12 months) of Koebner phenomenon and/or confetti-like or trichrome lesions. 12. Life expectancy is less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repigmentation | 24 weeks | Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Categorization of Repigmentation | 4, 12 and 24 weeks | Categorization of each study area in terms of ranges of percent repigmentation by a Blinded Evaluator (0-25%, 26-50%, 51-79%, 80-100%) |
| Responders | 24 weeks | Proportion of treated lesions achieving ≥80% or \<80% repigmentation as assessed by a Blinded Evaluator. |
| Subject Repigmentation Rating | 4, 12 and 24 weeks | Ratings of poor, moderate, good, or excellent |
| Blinded Evaluator Color Matching | 4, 12 and 24 weeks | Assessment of color matching (0-3: poor, moderate, good, excellent) inclusive of hypopigmentation and hyperpigmentation |
Countries
United States
Outcome results
None listed