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Evaluation of Scanoskin for the Assessment of Vitiligo

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ClinicalTrials.gov Identifier: NCT03133871
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
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
Vitiligo

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



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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT03133871


Contacts
Contact: Gabriella J Marchitelli 07960147859 ext 44 gabriella.marchitelli16@imperial.ac.uk
Contact: Doris Daby 020 3315 6825 ext 44 doris.daby@chelwest.nhs.uk

Locations
United Kingdom
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: Gabriella Marchitelli    7960147859 ext 44    gabriella.joy.m@gmail.com   
Contact: Doris Daby    020 3315 6825 ext 44    doris.daby@chelwest.nhs.uk   
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
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
ClinicalTrials.gov 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:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases