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Segmental VitiligoPhase 4NCT02458417

Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

A Phase 4 study testing ReCell, Full surface CO2 laser 200 mJ and Full surface CO2 laser 150 mJ in people with Segmental Vitiligo and Piebaldism, run by Netherlands Institute for Pigment Disorders at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Segmental Vitiligo, Piebaldism
What is being tested?
ReCell, Full surface CO2 laser 200 mJ and Full surface CO2 laser 150 mJ
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteNetherlands
Study dates
May 2015to Jan 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Netherlands Institute for Pigment disorders

    Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Official title: Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Study on the Recipient Site Preparation

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.

Read the detailed description

Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. With this device an epidermal cell suspension is created from a split skin graft, usually taken from the hip region. Currently, conventional ablative (full surface de-epidermisation) laser treatment in different laser settings is used as pre-treatment to prepare the acceptor site for transplantation. There is no evidence for the laser settings used and no studies are available on the use of a fractional laser as pre-treatment in autologous cell suspension grafting using ReCell (ReCell grafting). The investigators hypothesize that more superficial conventional ablative laser treatment and fractional ablative laser treatment are as effective as the current pre-treatment, whereas these treatments are less invasive, provide faster healing and prevent side effects like persisting erythema and scars. Furthermore, infiltration anaesthesia is not necessary with these less invasive treatments.

Being tested
ReCell, Full surface CO2 laser 200 mJ, Full surface CO2 laser 150 mJ, Fractional CO2 laser 7.5 mJ, 20%
Keywords
Ablative laser, Fractional laser, Vitiligo, Piebaldism, Cell suspension grafting
Medical subject headings
Piebaldism, Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReCellDevice

    Also called ReCell autologous cell suspension grafting

    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.

  • 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 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

  • 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.

Study groups in NCT02458417
Study groupRoleWhat they receive
Full surface CO2 laser 200mJ + ReCellActive comparatorThis 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.
Receives: Device: ReCell; Device: Full surface CO2 laser 200 mJ
Full surface CO2 laser 150mJ + ReCellExperimentalThis 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.
Receives: Device: ReCell; Device: Full surface CO2 laser 150 mJ
Fractional CO2 laser 7.5mJ 20% + ReCellExperimentalThis 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.
Receives: Device: ReCell; Device: Fractional CO2 laser 7.5 mJ, 20%
ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after intervention

Secondary outcomes (7)

  1. PhGA

    Blinded physician's assessment of repigmentation. Repigmentation will be classified as follows: 0-25%, 26-50%, 51-75%, 76-95%, 96-100% six months.

    Measured: 6 months after intervention

  2. Side effects

    Visual assessment of side effects per treatment region (erythema, hyperpigmentation, hypopigmentation and scar on a scale from 0-3) will be done by a blinded investigator six months.

    Measured: 6 months after intervention

  3. Reepithelialization

    One week after grafting reepithelialization will be assessed by a blinded physician and estimated on a 0 to 100% scale.

    Measured: 1 week after intervention

  4. Colour difference

    Colour difference i.e. the difference between normal pigmentation, erythema, and hyperpigmentation will be assessed with a DermaSpectrometer (Cortex Technology ApS, Hadsund, Denmark)

    Measured: 6 months after intervention

  5. PGA

    General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent).

    Measured: 6 months after intervention

  6. Pain

    One week after grafting, pain will be assessed after grafting on a 100 mm visual analogue scale (VAS) per treatment region

    Measured: 1 week after intervention

  7. Cell count

    The superfluous of the suspension will be used for flow cytometric analyses of the cellular composition of the graft.

    Measured: up to six hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02458417
Sponsor's protocol ID
NL49720.018.14
Status last verified
May 2015
First submitted
26 May 2015
Last updated
4 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • van Geel N, Ongenae K, Naeyaert JM. Surgical techniques for vitiligo: a review. Dermatology. 2001;202(2):162-6. doi: 10.1159/000051626.

    PubMed 11306848

  • Mulekar SV, Ghwish B, Al Issa A, Al Eisa A. Treatment of vitiligo lesions by ReCell vs. conventional melanocyte-keratinocyte transplantation: a pilot study. Br J Dermatol. 2008 Jan;158(1):45-9. doi: 10.1111/j.1365-2133.2007.08216.x. Epub 2007 Oct 10.

    PubMed 17927795

  • Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.

    PubMed 15216537

  • Brightman LA, Brauer JA, Anolik R, Weiss E, Karen J, Chapas A, Hale E, Bernstein L, Geronemus RG. Ablative and fractional ablative lasers. Dermatol Clin. 2009 Oct;27(4):479-89, vi-vii. doi: 10.1016/j.det.2009.08.009.

    PubMed 19850197

  • Hunzeker CM, Weiss ET, Geronemus RG. Fractionated CO2 laser resurfacing: our experience with more than 2000 treatments. Aesthet Surg J. 2009 Jul-Aug;29(4):317-22. doi: 10.1016/j.asj.2009.05.004.

    PubMed 19717066

  • 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.

    PubMed 12410698

  • 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.

    PubMed 8859294

  • Njoo MD, Westerhof W. Vitiligo. Pathogenesis and treatment. Am J Clin Dermatol. 2001;2(3):167-81. doi: 10.2165/00128071-200102030-00006.

    PubMed 11705094

  • Taieb A, Picardo M. Clinical practice. Vitiligo. N Engl J Med. 2009 Jan 8;360(2):160-9. doi: 10.1056/NEJMcp0804388. No abstract available.

    PubMed 19129529

  • 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.

    PubMed 8912558

  • 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.

    PubMed 15194144

  • 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.

    PubMed 20804490

  • 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.

    PubMed 19577331

  • 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.

    PubMed 15948977

  • 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.

    PubMed 21839315

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ReCell, Full surface CO2 laser 200 mJ and Full surface CO2 laser 150 mJ in people with Segmental Vitiligo and Piebaldism, run by Netherlands Institute for Pigment Disorders at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Repigmentation (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02458417, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.

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