- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03133871
Evaluation of Scanoskin for the Assessment of Vitiligo
September 27, 2019 updated by: Chelsea and Westminster NHS Foundation Trust
Comparison of Scanoskin With Planimetry as an Objective Measure of Vitiligo.
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW10 9NH
- Chelsea And Westminster Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders 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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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3 years
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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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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lucy J Thomas, MBChB, Chelsea and Westminster Hospital NHS Trust
- Study Director: Declan Colllins, MBBS, Chelsea and Westminster Hospital NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
November 20, 2018
Study Completion (Actual)
November 20, 2018
Study Registration Dates
First Submitted
April 21, 2017
First Submitted That Met QC Criteria
April 25, 2017
First Posted (Actual)
April 28, 2017
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 27, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C&W17/029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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