Autologous cell suspension grafting using ReCell in vitiligo and piebaldism patients: a randomized controlled study on the recipient site preparatio

Completed

Conditions: piebaldism
segmental vitiligo
10035023

Registration Number: NL-OMON42082

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

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
Cardial 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 involved
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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective assessment of the degree of repigmentation six months after<br /><br>autologous epidermal cell suspension grafting with a digital image analysing<br /><br>system.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Blinded physician*s assessment of repigmentation using standardized<br /><br>photographs.<br /><br>-General patient assessed outcome per treatment region on a scale from 0-3<br /><br>(poor, moderate, good or excellent).<br /><br>-Visual assessment of side effects per treatment region (hyperpigmentation,<br /><br>hypopigmentation and scarring on a scale from 0-3) by a blinded investigator.<br /><br>-The superfluous of the suspension will be used for cellular analyses, to<br /><br>investigate the density of melanocytes, keratinocytes, stem cells, viable<br /><br>melanocytes and keratinocytes in the cell suspension. </p><br>