Status:
COMPLETED
HI-Light Pilot Trial for Vitiligo: Hand Held NB-UVB for Early or Focal Vitiligo at Home
Lead Sponsor:
University of Nottingham
Conditions:
Vitiligo
Eligibility:
All Genders
5+ years
Phase:
NA
Brief Summary
This study is a small pilot randomised controlled trial (RCT) comparing hand-held NB-UVB light devices with placebo devices. These devices will be used by the participants to treat their vitiligo at h...
Detailed Description
This study is a pilot trial to determine the feasibility of conducting a subsequent large multi-centre RCT. The objectives of this pilot trial are: Primarily: 1. To establish the proportion of elig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01478945
Start Date
February 1 2012
End Date
April 1 2013
Last Update
August 23 2013
Active Locations (2)
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1
Queens Medical Centre,Nottingham University Hospitals NHS Trust
Nottingham, East Midlands, United Kingdom, NG7 2UH
2
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE1 5WW