What side effects are associated with this type of intervention?

Common treatments for vitiligo similar to the RECELL Device, such as autologous skin grafts and cellular suspensions, generally have side effects including infection at the donor or recipient site, scarring, and pigmentation irregularities. Other treatments like phototherapy can cause skin irritation, burns, and an increased risk of skin cancer with prolonged use. Topical corticosteroids, another common treatment, may lead to skin thinning, stretch marks, and acne.

What other types of research exist?

Promising novel alternatives to the RECELL Device for vitiligo treatment in 2024 include: 1) JAK inhibitors, which have shown potential in repigmentation by targeting the immune response involved in vitiligo. 2) Topical and oral ruxolitinib, a JAK inhibitor, has demonstrated efficacy in clinical trials. 3) Combination therapies involving phototherapy (e.g., narrowband UVB) with topical agents like tacrolimus or corticosteroids. These alternatives are based on recent clinical advancements and ongoing research in vitiligo treatment.

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Procedure

Spray-On Skin Cells for Vitiligo (TONE Trial)

Q: What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for vitiligo that directly involve autologous skin cell suspension like the RECELL Device. However, treatments for vitiligo generally include topical corticosteroids, calcineurin inhibitors, and light-based therapies such as narrowband UVB phototherapy. The RECELL Device represents a novel approach by using a patient's own skin cells to promote repigmentation, which is still under investigation.

N/A

Waitlist Available

Research Sponsored by Avita Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for people with stable vitiligo, a condition where patches of skin lose their color. The treatment uses the RECELL Device to create a mixture of the patient's own skin cells, which is then applied to the discolored areas. Patients also use a special light therapy at home to help improve the results.

Who is the study for?

This trial is for adults with stable vitiligo, which hasn't changed in the past year. They should have tried topical therapy or phototherapy without success and be willing to stick to their current immunosuppressive drugs and at-home phototherapy during the study. Participants must not use other treatments or join another trial for 24 weeks.

What is being tested?

The RECELL Device is being tested to see if it can repigment skin affected by vitiligo and improve patients' quality of life. The device uses a patient's own cells to create a spray-on treatment applied to depigmented areas.

What are the potential side effects?

Potential side effects may include typical risks associated with minor surgical procedures such as infection, scarring, or an allergic reaction to materials used during the process like trypsin or local anesthetics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study TreatmentExperimental Treatment1 Intervention

Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for vitiligo include topical corticosteroids, calcineurin inhibitors, and phototherapy, which aim to reduce inflammation and stimulate melanocyte activity. The RECELL Device, an autologous skin cell suspension, works by harvesting a patient's own skin cells, including melanocytes, and applying them to depigmented areas to promote repigmentation. Understanding these mechanisms is crucial for vitiligo patients as it helps them make informed decisions about their treatment options, manage expectations, and understand the potential for repigmentation and the importance of personalized treatment approaches.