Primary: to assess the efficacy and safety of RenovaCell grafting combined with 311 nm UVB therapy and topical anti-inflammatory therapy for the treatment of stable non-segmental vitiligo. Secondary: to assess, satisfaction, cosmetic acceptability,…
ID
Source
Brief title
Condition
- Pigmentation disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
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 RenovaCell Autologous Cell Harvesting Device (Avita
Medical Europe Limited, Cambridge, UK) (previous name: ReCell) is a device
which, compared to other forms of autologous epidermal cell suspension
grafting, is easier in use showing similar results. Efficacy and safety of the
ReCell device was proven in segmental vitiligo and piebaldism. However, the
efficacy in non-segmental vitiligo is not yet confirmed in randomized
controlled trials. We hypothesize that grafting using the RenovaCell device in
combination with standard of care is also effective in stable non-segmental
vitiligo and more effective than standard of care alone.
Study objective
Primary: to assess the efficacy and safety of RenovaCell grafting combined with
311 nm UVB therapy and topical anti-inflammatory therapy for the treatment of
stable non-segmental vitiligo.
Secondary: to assess, satisfaction, cosmetic acceptability, noticeability and
persistence of repigmentation after RenovaCell transplantation.
Study design
Prospective, observer-blinded, randomised, within subject, controlled, study.
Intervention
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. Standard of care will be given
according to the standard treatment protocol of our institute.
Study burden and risks
As the study involves large depigmented lesions, which are too large to treat
in regular surgical treatment (punch grafting), patients will not miss any
regular treatment. The time investment for the patient will be approximately 20
minutes for the punchgrafting session, 75 minutes for the cell suspension
grafting session and 15 minutes for the three follow-up visits. Two of the five
visits are part of the standard of care UVB follow-up regimen and are therefore
not additional due to the study. Infection in the grafted area or the donor
site may occur but is very rare; the risk of mild textural changes in the donor
site is moderate. Hyperpigmentation of the treated area does occur often,
although this improves over time in most cases. In case of improvement of the
depigmentation, patients may receive another treatment for the (contralateral)
untreated side.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57683.018.16 |