Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

Phase 4

Completed

• Conditions: Segmental Vitiligo; Piebaldism

• Registration Number: NCT02458417
• Lead Sponsor: Netherlands Institute for Pigment Disorders

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.

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-06-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Repigmentation	6 months after intervention	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

Name	Time	Method
PhGA	6 months after intervention	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	6 months after intervention	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	1 week after intervention	One week after grafting reepithelialization will be assessed by a blinded physician and estimated on a 0 to 100% scale.
Colour difference	6 months after intervention	Colour difference i.e. the difference between normal pigmentation, erythema, and hyperpigmentation will be assessed with a DermaSpectrometer (Cortex Technology ApS, Hadsund, Denmark)
PGA	6 months after intervention	General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent).
Pain	1 week after intervention	One week after grafting, pain will be assessed after grafting on a 100 mm visual analogue scale (VAS) per treatment region
Cell count	up to six hours	The superfluous of the suspension will be used for flow cytometric analyses of the cellular composition of the graft.

Trial Locations

Locations (1)

Netherlands Institute for Pigment disorders; 🇳🇱 Amsterdam, Netherlands