Vitiligo - Clinical trial details 

HI-Light Pilot Trial for Vitiligo: Hand Held NB-UVB for Early or Focal Vitiligo at Home

Recruitment status:
Not recruiting
Primary Sponsor:
University of Nottingham
Recruitment countries:
United Kingdom
Health condition studied:
Vitiligo
URL:
Link to the clinical trial website

About the trial

Interventions:
Device: 311 nm NB-UVB light
Key inclusion and exclusion criteria:

  • Inclusion Criteria:

    - Participants with a diagnosis of vitiligo confirmed by dermatologist. Participants
    with focal disease, less than 25% of body surface area.

    - Age: children and adults (no upper age limit). The child has to be older than 5 years
    old and/or mature enough to understand that the eyes must be kept closed, and to stay
    still for the duration of treatment.

    - No therapy for vitiligo in the previous 2 weeks and no other vitiligo treatment
    during the trial other than as per trial protocol.

    - Participants with both spreading and stable disease

    - Participants able to give informed consent. We will aim to treat all vitiligo
    lesions, however the participant (and parent/legal guardian if the participant is a
    child) and research nurse will agree at the beginning of the trial if there are any
    lesions participants would not want to be treated, such as on non exposed sites or
    areas difficult to reach to treat, e.g. back.

    Exclusion Criteria:

    - Segmental vitiligo

    - Universal vitiligo

    - Previous history of skin cancer

    - Recent or concurrent radiotherapy

    - Photosensitivity

    - Use of immunosuppressive or photosensitive drugs

    - Pregnant or lactating women

    - Any major medical co-morbidities

    - Vitiligo lesions on genitalia should not be treated
  • Age minimum:  5 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
Proportion of eligible participants, willing to be randomised.
Secondary outcomes:
Incidence of NB-UVB short term adverse events
Number of participants accepting the initial invitation to participate
Outcome measures for the main large trial will also be tested. These will include: repigmentation rate of vitiliginous lesions, cessation of spreading of vitiligo, impact on the quality of life of participants.
Proportion of participants (or their parent/legal guardian) who are satisfied with the treatment and the hand held units.
Proportion of participants adhering to the treatment protocol
Proportion of participants for whom the blinding of the assessor and the allocated group is maintained
Proportion of participants fulfilling trial eligibility criteria
Target sample size:
29
Study type:
Interventional
Study design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Contacts:
  • Name:   Anton Alexandroff, PhD MRCP
  • Address: 
  • Phone: 
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  • Affiliation:  University Hospitals, Leicester
  • Name:   Hywel C. Williams, MSc PhD FRCP
  • Address: 
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  • Affiliation:  Centre of Evidence Based Dermatology
  • Name:   Jane C Ravenscroft, MB ChB, MRCP
  • Address: 
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  • Affiliation:  Queen's Medical Centre
  • Name:   Viktoria Eleftheriadou, MD
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Centre of Evidence Based Dermatology

Technical details

Scientific title:
Pilot Randomised Controlled Trial of Hand Held NB-UVB for the Treatment of Focal or Early Vitiligo at Home
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT01478945
Secondary ID:
PR-PG-040710177
11/EM/0331
Register:
ClinicalTrials.gov
Date of registration:
15/11/2011
Date of first enrollment:
February 2012
Last refreshed:
26 August 2013

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