Clinical trial NCT03133871: Evaluation of Scanoskin for the Assessment of Vitiligo
Official title: Comparison of Scanoskin With Planimetry as an Objective Measure of Vitiligo.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitiligo
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients attending outpatient dermatology clinics at Chelsea \& Westminster Hospital and diagnosed with vitiligo will be invited to take part in the study

Brief summary: The aim of this study is to establish whether the use of a special digital camera (SIAscopy) can provide an accurate and reliable measure of vitiligo which is at least equivalent to the current gold standard of planimetry. If so, SIAscopy could be used as an objective diagnostic and prognostic tool in the management of vitiligo patients within dermatology departments and allow a fair and accurate assessment of new potential treatments.

Detailed description: Vitiligo is a common, disfiguring skin complaint which affects between 0.5 and 2% of the world population and which presents with de-pigmented patches of skin. Highly stigmatising it has a profound psychological impact on those affected and negatively impacts quality of life. Efficacy of current therapies which include topical steroids/calcineurin inhibitors and ultraviolet light are limited and new treatments are required. Numerous papers including the 2010 Cochrane review have highlighted the need for a consensus on outcome measures which could then facilitate meta-analyses and provide robust clinical recommendations. No standard method of measuring skin re-pigmentation has been identified to date and current best practice relies on clinician assessment and use of various non-standardised grading systems (of which there are over 40 none of which has been proven superior or accepted by the consensus of clinicians) and in addition are neither robust nor objective. Measurement of skin pigment levels can be achieved using portable devices such as Spectrophotometric Intracutaneous Analysis scope (SIAscope) using an imaging modality called ScanoskinTM. Unlike other digital methods reported in the literature, this has been validated as a quantitative measure of melanin content in the skin, it is portable, easy to use and not prohibitively expensive. The aim of this study is to determine if ScanoskinTM is equivalent to the current gold standard of planimetry (mainly used in research setting) for establishing extent of vitiligo. In addition the investigators want to assess whether it offers a more objective standardised measure of vitiligo compared with clinician assessment (current accepted best clinical practice) which could then be utilised to provide a meaningful assessment of new and existing treatment modalities. In addition the investigators will assess whether ScanoskinTM is able to identify subclinical disease which could affect clinical decisions regarding treatment strategies and also assess whether improvements in pigmentation correlate with patient satisfaction and quality of life scores.

Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with vitiligo (any form) by a Consultant Dermatologist/Specialist Dermatology trainee.
* Who undergo any form of treatment or observation.
* Informed consent for enrolment into the study.
* Referred for assessment and treatment at Chelsea \& Westminster Hospital Dermatology Department.

Exclusion Criteria:

* Patients not consenting to participate.
* Patients with insufficient English to comprehend the Patient Information Sheet (regrettably we are unable to offer translation services for this scope).
* Patients without capacity to comprehend the Patient Information Sheet would be deemed unable to give informed consent and therefore not included.
* Patients unable to undertake the imaging process for whatever reason.
* Patients unable to attend for follow up assessment

Primary outcomes:
measure: Comparison of Scanoskin with planimetry as an objective measure of vitiligo.
timeFrame: 3 years
Secondary outcomes:
measure: Determine whether Scanoskin can identify subclinical disease
timeFrame: 3 years
measure: Determine whether Scanoskin can identify subclinical response to treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Chelsea and Westminster Hospital NHS Trust
name: Lucy J Thomas, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Chelsea and Westminster Hospital NHS Trust
name: Declan Colllins, MBBS
role: STUDY_DIRECTOR
References: