NCT02458417

Brief Summary

The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2 laser abrasion with superficial full surface ablation, fractional laser treatment and conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the patient reported outcome and to assess the cellular composition of the graft.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 4, 2017

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

May 26, 2015

Last Update Submit

March 31, 2017

Conditions

Segmental VitiligoPiebaldism

Keywords

Ablative laserFractional laserVitiligoPiebaldismCell suspension grafting

Outcome Measures

Primary Outcomes (1)

  • Repigmentation

    Assessment will be done by sheets and a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before and six months after treatment, after which the sheets are scanned using a predefined resolution. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch are computed.

    6 months after intervention

Secondary Outcomes (7)

  • PhGA

    6 months after intervention

  • Side effects

    6 months after intervention

  • Reepithelialization

    1 week after intervention

  • Colour difference

    6 months after intervention

  • PGA

    6 months after intervention

  • +2 more secondary outcomes

Other Outcomes (3)

  • Skin type

    week 0

  • VIDA score

    week 0

  • Duration of disease

    week 0

Study Arms (4)

Full surface CO2 laser 200mJ + ReCell

ACTIVE COMPARATOR

This test region will receive full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 209 µm) and density 3. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.

Device: ReCellDevice: Full surface CO2 laser 200 mJ

Full surface CO2 laser 150mJ + ReCell

EXPERIMENTAL

This test region will receive full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.

Device: ReCellDevice: Full surface CO2 laser 150 mJ

Fractional CO2 laser 7.5mJ 20% + ReCell

EXPERIMENTAL

This test region will receive pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.

Device: ReCellDevice: Fractional CO2 laser 7.5 mJ, 20%

Control

NO INTERVENTION

No intervention

Interventions

ReCellDEVICE

A split-thickness skin biopsy will be taken from the hip region of the patient. The skin biopsy that is obtained will be treated in the ReCell kit (Avita Medical Europe Ltd, Cambridge, UK): it will be placed in the heated enzyme solution, containing trypsin, in the device for 15-20 minutes to allow cell disaggregation. After that period, the biopsy will be taken from the enzyme solution and will be dipped in sodium lactate buffer solution. The biopsy will then be scraped to disaggregate the cells from the dermal epidermal junction. The epidermal cells are drawn up in a syringe. The prepared suspension will be dripped on both donor and acceptor site.

Also known as: ReCell autologous cell suspension grafting
Fractional CO2 laser 7.5mJ 20% + ReCellFull surface CO2 laser 150mJ + ReCellFull surface CO2 laser 200mJ + ReCell
Full surface CO2 laser 200 mJDEVICE

Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 144 µm) and density 3

Full surface CO2 laser 200mJ + ReCell
Full surface CO2 laser 150 mJDEVICE

Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3

Full surface CO2 laser 150mJ + ReCell
Fractional CO2 laser 7.5 mJ, 20%DEVICE

Pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density.

Fractional CO2 laser 7.5mJ 20% + ReCell

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with, segmental vitiligo or piebaldism under medical treatment at the Netherlands Institute for Pigment Disorders
  • Age ≥18
  • Patient is willing and able to give written informed consent
  • Segmental vitiligo stable since 12 months without systemic therapy or 12 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions.
  • At least four depigmented lesions on the proximal extremities or trunk larger than 3x3 cm or one depigmented lesion on the proximal extremities or trunk of at least 12x3 cm.

You may not qualify if:

  • UV therapy or systemic immunosuppressive treatment during the last 12 months
  • Local treatment of vitiligo during the last 12 months
  • Vitiligo lesions with follicular or non-follicular repigmentations
  • Skin type I
  • Recurrent HSV skin infections
  • Hypertrophic scars
  • Keloid
  • Cardiac insufficiency
  • Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anaesthesia.
  • Patients who are pregnant or breast-feeding
  • Patients not competent to understand what the procedures involves
  • Patients with a personal history of melanoma or non-melanoma skin cancer
  • Patients with atypical nevi.
  • Known allergy to clarithromycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Institute for Pigment disorders

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (33)

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  • Olsson MJ, Juhlin L. Long-term follow-up of leucoderma patients treated with transplants of autologous cultured melanocytes, ultrathin epidermal sheets and basal cell layer suspension. Br J Dermatol. 2002 Nov;147(5):893-904. doi: 10.1046/j.1365-2133.2002.04837.x.

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  • Drake LA, Dinehart SM, Farmer ER, Goltz RW, Graham GF, Hordinsky MK, Lewis CW, Pariser DM, Skouge JW, Turner ML, Webster SB, Whitaker DC, Lowery BJ, Nordlund JJ, Grimes PE, Halder RM, Minus HR. Guidelines of care for vitiligo. American Academy of Dermatology. J Am Acad Dermatol. 1996 Oct;35(4):620-6. doi: 10.1016/s0190-9622(96)90691-x. No abstract available.

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  • Hann SK, Lee HJ. Segmental vitiligo: clinical findings in 208 patients. J Am Acad Dermatol. 1996 Nov;35(5 Pt 1):671-4. doi: 10.1016/s0190-9622(96)90718-5.

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  • Murakami T, Fukai K, Oiso N, Hosomi N, Kato A, Garganta C, Barnicoat A, Poppelaars F, Aquaron R, Paller AS, Ishii M. New KIT mutations in patients with piebaldism. J Dermatol Sci. 2004 Jun;35(1):29-33. doi: 10.1016/j.jdermsci.2004.03.003.

    PMID: 15194144BACKGROUND

  • van Geel N, Wallaeys E, Goh BK, De Mil M, Lambert J. Long-term results of noncultured epidermal cellular grafting in vitiligo, halo naevi, piebaldism and naevus depigmentosus. Br J Dermatol. 2010 Dec;163(6):1186-93. doi: 10.1111/j.1365-2133.2010.10014.x.

    PMID: 20804490BACKGROUND

  • Linthorst Homan MW, Spuls PI, de Korte J, Bos JD, Sprangers MA, van der Veen JP. The burden of vitiligo: patient characteristics associated with quality of life. J Am Acad Dermatol. 2009 Sep;61(3):411-20. doi: 10.1016/j.jaad.2009.03.022. Epub 2009 Jul 3.

    PMID: 19577331BACKGROUND

  • Ongenae K, Van Geel N, De Schepper S, Naeyaert JM. Effect of vitiligo on self-reported health-related quality of life. Br J Dermatol. 2005 Jun;152(6):1165-72. doi: 10.1111/j.1365-2133.2005.06456.x.

    PMID: 15948977BACKGROUND

  • Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.

    PMID: 21839315BACKGROUND

  • Fongers A, Wolkerstorfer A, Nieuweboer-Krobotova L, Krawczyk P, Toth GG, van der Veen JP. Long-term results of 2-mm punch grafting in patients with vitiligo vulgaris and segmental vitiligo: effect of disease activity. Br J Dermatol. 2009 Nov;161(5):1105-11. doi: 10.1111/j.1365-2133.2009.09367.x. Epub 2009 Jun 22.

    PMID: 19673878BACKGROUND

  • Falabella R. Grafting and transplantation of melanocytes for repigmenting vitiligo and other types of leukoderma. Int J Dermatol. 1989 Jul-Aug;28(6):363-9. doi: 10.1111/j.1365-4362.1989.tb02479.x. No abstract available.

    PMID: 2670786BACKGROUND

  • Gawkrodger DJ, Ormerod AD, Shaw L, Mauri-Sole I, Whitton ME, Watts MJ, Anstey AV, Ingham J, Young K; Therapy Guidelines and Audit Subcommittee, British Association of Dermatologists; Clinical Standards Department, Royal College of Physicians of London; Cochrane Skin Group; Vitiligo Society. Guideline for the diagnosis and management of vitiligo. Br J Dermatol. 2008 Nov;159(5):1051-76. doi: 10.1111/j.1365-2133.2008.08881.x.

    PMID: 19036036BACKGROUND

  • Gawkrodger DJ, Ormerod AD, Shaw L, Mauri-Sole I, Whitton ME, Watts MJ, Anstey AV, Ingham J, Young K. Vitiligo: concise evidence based guidelines on diagnosis and management. Postgrad Med J. 2010 Aug;86(1018):466-71. doi: 10.1136/pgmj.2009.093278.

    PMID: 20709768BACKGROUND

  • Malakar S, Dhar S. Treatment of stable and recalcitrant vitiligo by autologous miniature punch grafting: a prospective study of 1,000 patients. Dermatology. 1999;198(2):133-9. doi: 10.1159/000018089.

    PMID: 10325459BACKGROUND

  • Boersma BR, Westerhof W, Bos JD. Repigmentation in vitiligo vulgaris by autologous minigrafting: results in nineteen patients. J Am Acad Dermatol. 1995 Dec;33(6):990-5. doi: 10.1016/0190-9622(95)90292-9.

    PMID: 7490371BACKGROUND

  • Mulekar SV. Long-term follow-up study of segmental and focal vitiligo treated by autologous, noncultured melanocyte-keratinocyte cell transplantation. Arch Dermatol. 2004 Oct;140(10):1211-5. doi: 10.1001/archderm.140.10.1211.

    PMID: 15492183BACKGROUND

  • Gravante G, Di Fede MC, Araco A, Grimaldi M, De Angelis B, Arpino A, Cervelli V, Montone A. A randomized trial comparing ReCell system of epidermal cells delivery versus classic skin grafts for the treatment of deep partial thickness burns. Burns. 2007 Dec;33(8):966-72. doi: 10.1016/j.burns.2007.04.011. Epub 2007 Sep 29.

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    PMID: 22079538BACKGROUND

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  • Linthorst Homan MW, Wolkerstorfer A, Sprangers MA, van der Veen JP. Digital image analysis vs. clinical assessment to evaluate repigmentation after punch grafting in vitiligo. J Eur Acad Dermatol Venereol. 2013 Feb;27(2):e235-8. doi: 10.1111/j.1468-3083.2012.04568.x. Epub 2012 May 23.

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MeSH Terms

Conditions

PiebaldismVitiligo

Condition Hierarchy (Ancestors)

AlbinismEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsSkin Diseases, GeneticHypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Albert Wolkerstorfer, MD, PhD

    Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam

    PRINCIPAL INVESTIGATOR

  • Menno A. De Rie, MD, PhD

    Department of Dermatology, Academic Medical Center, University of Amsterdam

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 1, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 4, 2017

Record last verified: 2015-05

Locations

NL(1)