Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

Netherlands Institute for Pigment Disorders

Status and phase: Completed; Phase 4

Conditions: Piebaldism; Segmental Vitiligo

Treatments: Device: Full surface CO2 laser 200 mJ; Device: Full surface CO2 laser 150 mJ; Device: Fractional CO2 laser 7.5 mJ, 20%; Device: ReCell

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02458417

NL49720.018.14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 4 patient groups

Full surface CO2 laser 200mJ + ReCell

Active Comparator group

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.

Treatment:

Device: ReCell

Device: Full surface CO2 laser 200 mJ

Full surface CO2 laser 150mJ + ReCell

Experimental group

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.

Treatment:

Device: ReCell

Device: Full surface CO2 laser 150 mJ

Fractional CO2 laser 7.5mJ 20% + ReCell

Experimental group

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.

Treatment:

Device: ReCell

Device: Fractional CO2 laser 7.5 mJ, 20%

Control

No Intervention group

Description:

No intervention