non-segmental vitiligo vitiligo
Conditions
Interventions
In patients already receiving standard of care (311 nm UVB therapy + topical
anti-inflammatory therapy) 2 comparable depigmented regions are randomised to
receive RenovaCell grafting or no grafting.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective assessment of the degree of repigmentation three and six months after RenovaCell grafting with a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before, three and six months after treatment, after which the sheets are scanned. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch is computed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: - Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability - General patient assessed outcome per treatment region on a scale from 0-3 (poor, moderate, good or excellent). - Visual assessment of percentage repigmentation by blinded observer - Visual assessment of side effects per treatment region (hyperpigmentation, hypopigmentation and scarring on a scale from 0-3) by a blinded investigator. - The superfluous of the suspension and residual lesional punchgrafts will be used for flow cytometric analyses of the cellular composition of the grafted cell suspension, and expression analysis of melanin synthesis-related genes. These data will be correlated to the clinical data. | — |
Countries
Netherlands
Outcome results
None listed