Evaluation of Scanoskin for the Assessment of Vitiligo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03133871
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

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.

Condition or disease

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.

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Comparison of Scanoskin With Planimetry as an Objective Measure of Vitiligo.
Estimated Study Start Date : April 28, 2017
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. Determine whether Scanoskin can identify subclinical response to treatment [ Time Frame: 3 years ]
    Comparing images to non affected areas over time

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03133871

Contact: Gabriella J Marchitelli 07960147859 ext 44
Contact: Doris Daby 020 3315 6825 ext 44

United Kingdom
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: Gabriella Marchitelli    7960147859 ext 44   
Contact: Doris Daby    020 3315 6825 ext 44   
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Principal Investigator: Lucy J Thomas, MBChB Chelsea and Westminster Hospital NHS Trust
Study Director: Declan Colllins, MBBS Chelsea and Westminster Hospital NHS Trust

Responsible Party: Chelsea and Westminster NHS Foundation Trust Identifier: NCT03133871     History of Changes
Other Study ID Numbers: C&W17/029
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases