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Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

Primary Purpose

Segmental Vitiligo, Piebaldism

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
ReCell
Full surface CO2 laser 200 mJ
Full surface CO2 laser 150 mJ
Fractional CO2 laser 7.5 mJ, 20%
Sponsored by
Netherlands Institute for Pigment Disorders
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Segmental Vitiligo focused on measuring Ablative laser, Fractional laser, Vitiligo, Piebaldism, Cell suspension grafting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Netherlands Institute for Pigment disorders

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

No Intervention

Arm Label

Full surface CO2 laser 200mJ + ReCell

Full surface CO2 laser 150mJ + ReCell

Fractional CO2 laser 7.5mJ 20% + ReCell

Control

Arm Description

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.

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.

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.

No intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Reepithelialization
One week after grafting reepithelialization will be assessed by a blinded physician and estimated on a 0 to 100% scale.
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)
PGA
General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent).
Pain
One week after grafting, pain will be assessed after grafting on a 100 mm visual analogue scale (VAS) per treatment region
Cell count
The superfluous of the suspension will be used for flow cytometric analyses of the cellular composition of the graft.

Full Information

First Posted
May 26, 2015
Last Updated
March 31, 2017
Sponsor
Netherlands Institute for Pigment Disorders
Collaborators
Avita Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02458417
Brief Title
Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients
Official Title
Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Study on the Recipient Site Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Netherlands Institute for Pigment Disorders
Collaborators
Avita Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Segmental Vitiligo, Piebaldism
Keywords
Ablative laser, Fractional laser, Vitiligo, Piebaldism, Cell suspension grafting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full surface CO2 laser 200mJ + ReCell
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Full surface CO2 laser 150mJ + ReCell
Arm Type
Experimental
Arm Description
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.
Arm Title
Fractional CO2 laser 7.5mJ 20% + ReCell
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
ReCell
Other Intervention Name(s)
ReCell autologous cell suspension grafting
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Full surface CO2 laser 200 mJ
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Full surface CO2 laser 150 mJ
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Fractional CO2 laser 7.5 mJ, 20%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Repigmentation
Description
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.
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
PhGA
Description
Blinded physician's assessment of repigmentation. Repigmentation will be classified as follows: 0-25%, 26-50%, 51-75%, 76-95%, 96-100% six months.
Time Frame
6 months after intervention
Title
Side effects
Description
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.
Time Frame
6 months after intervention
Title
Reepithelialization
Description
One week after grafting reepithelialization will be assessed by a blinded physician and estimated on a 0 to 100% scale.
Time Frame
1 week after intervention
Title
Colour difference
Description
Colour difference i.e. the difference between normal pigmentation, erythema, and hyperpigmentation will be assessed with a DermaSpectrometer (Cortex Technology ApS, Hadsund, Denmark)
Time Frame
6 months after intervention
Title
PGA
Description
General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent).
Time Frame
6 months after intervention
Title
Pain
Description
One week after grafting, pain will be assessed after grafting on a 100 mm visual analogue scale (VAS) per treatment region
Time Frame
1 week after intervention
Title
Cell count
Description
The superfluous of the suspension will be used for flow cytometric analyses of the cellular composition of the graft.
Time Frame
up to six hours
Other Pre-specified Outcome Measures:
Title
Skin type
Description
Fitzpatrick skin type
Time Frame
week 0
Title
VIDA score
Description
Classification of disease activity according to VIDA scale
Time Frame
week 0
Title
Duration of disease
Description
Duration of disease
Time Frame
week 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Wolkerstorfer, MD, PhD
Organizational Affiliation
Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Menno A. De Rie, MD, PhD
Organizational Affiliation
Department of Dermatology, Academic Medical Center, University of Amsterdam
Official's Role
Study Director
Facility Information:
Facility Name
Netherlands Institute for Pigment disorders
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

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Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

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