Clinical Trial: Evaluation of Scanoskin for the Assessment of Vitiligo

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Comparison of Scanoskin With Planimetry as an Objective Measure of Vitiligo.

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 Summary: 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 treatm
Sponsor: Chelsea and Westminster NHS Foundation Trust

Current Primary Outcome: Comparison of Scanoskin with planimetry as an objective measure of vitiligo. [ Time Frame: 3 years ]

Comparing planimetry to Scanoskin ability to work out surface area and percentage pigmentation of vitiligo lesions


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Determine whether Scanoskin can identify subclinical disease [ Time Frame: 3 years ]
    Taking standardised Scanoskin images of unaffected skin over time to determine if Scanoskin can pick up subclinical disease
  • Determine whether Scanoskin can identify subclinical response to treatment [ Time Frame: 3 years ]
    Comparing images to non affected areas over time


Original Secondary Outcome: Same as current

Information By: Chelsea and Westminster NHS Foundation Trust

Dates:
Date Received: April 21, 2017
Date Started: April 28, 2017
Date Completion: April 20, 2020
Last Updated: April 25, 2017
Last Verified: April 2017