Spray-On Skin™ Cells 1:20 with NB-UVB for Vitiligo

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VitiligoSpray-On Skin™ Cells 1:20 with NB-UVB - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new spray-on skin cell treatment for people with vitiligo, a condition that causes patches of skin to lose color.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Week 36 and 52

Week 24
Central Review Committee categorization of repigmentation
Central review committee assessment of color matching at Week 24
Investigator assessment of color matching at Week 24
Investigator assessment of color matching for the study areas
Investigator assessment of pigmentation responder for the study areas
Investigator assessment of repigmentation category
Investigator assessment of repigmentation responder for the study areas
Investigator study area Vitiligo Area Scoring Index (VASI) scores, change from baseline
Investigator study area Vitiligo Area Scoring Index (VASI) scores, change from baseline to Week 24
Patient Global Impression of Change - Vitiligo (PaGIC-V)
Proportion of Responders for RECELL-treated areas versus Control at Week 24
Subject and Investigator global treatment success and donor site satisfaction
Subject and investigator global treatment success and donor site satisfaction
Subject-reported Vitiligo Noticeability Score for Week 24 vs baseline
Week 36 and 52
Central Review Committee and Investigator assessment of pigmentation
Central Review Committee assessment of color matching
Week 52
Repigmentation durability

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

NB-UVB only
1 of 3
All Participants (within patient control)
1 of 3
Spray-On Skin™ Cells 1:20 with NB-UVB
1 of 3

Active Control

Experimental Treatment

49 Total Participants · 3 Treatment Groups

Primary Treatment: Spray-On Skin™ Cells 1:20 with NB-UVB · No Placebo Group · N/A

All Participants (within patient control)Experimental Group · 2 Interventions: Spray-On Skin™ Cells 1:20 followed by NB-UVB, NB-UVB only · Intervention Types: Device, Device
Spray-On Skin™ Cells 1:20 with NB-UVB
Procedure
Experimental Group · 1 Intervention: Spray-On Skin™ Cells 1:20 with NB-UVB · Intervention Types: Procedure
NB-UVB only
Device
ActiveComparator Group · 1 Intervention: NB-UVB only · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 36 and 52

Who is running the clinical trial?

Avita MedicalLead Sponsor
14 Previous Clinical Trials
516 Total Patients Enrolled
3 Trials studying Vitiligo
32 Patients Enrolled for Vitiligo

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
which The text states that both groups have the same amount of leukotrichia.
medical and topical treatments The patient is a good candidate for surgery to remove a depigmented area, which is defined as a patient who has been compliant with treatment but has not seen a good response.
Photo documentation of the patient's depigmented areas have been evaluated as stable by an independent Screening Committee
The patient has not been treated with phototherapy in the past 90 days.
You need to use topical therapy and a minimum of 3 months of phototherapy.
The individual has stable vitiligo, which is not getting worse and has not gotten worse in the last year.
The patient has not used any topical treatments (e.g., steroids, tacrolimus) on the study areas in the past 90 days.
The spaces are between 16cm2 and 456cm2.
The text is saying that both animals are exposed to the sun similarly.

Who else is applying?

What state do they live in?
Tennessee25.0%
Georgia25.0%
California25.0%
Other25.0%
How old are they?
18 - 6575.0%
65+25.0%
What site did they apply to?
West Dermatology50.0%
Medical University of South Carolina50.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call100.0%
Most responsive sites:
  1. West Dermatology: < 48 hours