Autologous cell suspension grafting using ReNovaCell in non-segmental vitiligo patients: a randomized controlled study

Completed

Conditions: non-segmental vitiligo
vitiligo
10035023

Registration Number: NL-OMON46274

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

• Patients with, non-segmental vitiligo receiving 6 months of standard of care, consisting of topical corticosteroids or immune modulators and NB-UVB phototherapy
• Age >=18
• Patient is willing and able to give written informed consent
• At least two comparable (in location and diameter) depigmented lesions of at least 10 cm2 or one large lesion of at least 30 cm2 on the extremities, face or trunk - excluding fingers, elbows, feet and knees.

Exclusion Criteria

- Patients with signs of activity (spreading of lesions and/or koebnerisation) during standard of care treatment or showing depigmentation in the test punch grafting
- 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective assessment of the degree of repigmentation three and six months after<br /><br>RenovaCell grafting with a digital image analysis system. To assess the<br /><br>pigmentation, the contours of pigmentation are copied on a transparent sheet<br /><br>before, three and six months after treatment, after which the sheets are<br /><br>scanned. By comparing pre- and post-treatment pictures, the relative surface<br /><br>showing repigmentation expressed as percentage of the selected treated patch is<br /><br>computed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes:<br /><br>- Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability<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 percentage repigmentation by blinded observer<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 and residual lesional punchgrafts will be<br /><br>used for flow cytometric analyses of the cellular composition of the grafted<br /><br>cell suspension, and expression analysis of melanin synthesis-related genes.<br /><br>These data will be correlated to the clinical data.</p><br>