Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions

Vitiligo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547998
• Other study ID #: CTP009
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: August 2023
• Source: Avita Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 31, 2023
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Device:
• Control Intervention (UVB)
Targeted narrowband-UVB phototherapy in alignment with published Vitiligo Working Group recommendations.
• Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)
Spray-On Skin™ Cells prepared using RECELL will be applied to an area prepared by ablative laser, followed by targeted narrowband UVB phototherapy.

Locations

Country	Name	City	State
United States	University of Texas at Austin Dell Medical School	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Henry Ford Health System	Detroit	Michigan
United States	Skin Care Research, LLC	Hollywood	Florida
United States	Heights Dermatology	Houston	Texas
United States	University of California, Irvine	Irvine	California
United States	Miami Dermatology and Laser Institute	Miami	Florida
United States	University of California, Davis	Sacramento	California
United States	West Dermatology	San Diego	California
United States	DMR Research	Westport	Connecticut
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Avita Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of =80% Study Area Repigmentation	Repigmentation was evaluated by qualified members of a Central Review Committee.	Week 24
Secondary	Repigmentation Category	Expert Central Review Committee categorization of the amount of area repigmented (0-25%, 26-50%, 51-79% and 80-100%). This is visual estimation of the vitiligo lesion area that has repigmented, with reference to training images. Higher %repigmentation is a better outcome.	Week 24
Secondary	Color Matching	The Expert Central Review Committee visually judged the quality of repigmentation in terms of how closely it matches with the normal pigmentation seen in the surrounding area. The rating scale consists of poor, moderate, good, and excellent. Color matching can only be evaluated in instances of >0% repigmentation.	Week 24