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

NCT01478945 | Completed

• 2 other identifiers: 11/EM/0331PR-PG-040710177
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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 home for a period of four months. The main purpose of the trial is to provide feasibility data that can be used to inform the design of a future multi-centre RCT of these devices. Two hand-held UVB devices with similar manual operating system are being tested during this pilot study. This trial will help the investigators to establish which device is likely to be best for the main trial. Participants will be approached in a variety of ways (through secondary care, primary care and through direct advertising). Potential participants who contact the co-ordinating centre expressing an interest in the trial will be given more information about the trial, checked for preliminary eligibility, and sent an appointment for a screening visit at the closest recruiting hospital (Nottingham or Leicester). This screening visit will be conducted by a research nurse, but a dermatologist will also be present in order to confirm the diagnosis of vitiligo and to confirm the participant's suitability for UVB treatment at home. If eligible and willing to take part in the trial, participants will provide written informed consent and baseline data will be collected. In order to define the starting dose to be used when treating the vitiligo, a minimum erythema dose (MED) test will be conducted. An educational session will be provided by the research nurse outlining how to use the devices, how to assess side-effects of the treatment and how to complete the treatment diary. It is anticipated that the screening visit and educational session will take place on the same day and may take up to 1.5 hours. On the following day, a brief visit to the hospital will be required in order to examine the skin and read the MED results (if more convenient, the educational session may be delivered at this time). Once this has been done, participants will be given the devices to use at home - treatment is applied 3 times per week on alternate days. They will be followed up by telephone at week 1, week 2 and week 12 - in order to provide support and to monitor side-effects. Participants will be asked to keep a treatment diary that records when the treatment has been used and records side-effects experienced. Emergency contact details will be provided in case of urgent medical need. Participants will continue with treatment at home for the 16-week trial period. Two further hospital visits will take place in order to record outcome data

Conditions

Vitiligo

Keywords

vitiligo; early vitiligo; focal vitiligo

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible participants, willing to be randomised.

  To establish the proportion of eligible participants and their willingness to be randomised to home NB-UVB

  4 to 6 months

Secondary Outcomes (7)

• Number of participants accepting the initial invitation to participate

  4 to 6 months

• Proportion of participants fulfilling trial eligibility criteria

  4 to 6 months

• Proportion of participants adhering to the treatment protocol

  4 months

• Proportion of participants (or their parent/legal guardian) who are satisfied with the treatment and the hand held units.

  4 months

• Proportion of participants for whom the blinding of the assessor and the allocated group is maintained

  4 months

Study Arms (3)

Dermfix 1000 active 311 nm NB-UVB

ACTIVE COMPARATOR

Active hand held NB-UVB unit: Manual device administering NB-UVB

Device: 311 nm NB-UVB light

Waldmann active 311 nm NB-UVB

ACTIVE COMPARATOR

Active hand held NB-UVB unit: Manual device administering NB-UVB (Waldmann)

Device: 311 nm NB-UVB light

Dermfix 1000 placebo

SHAM COMPARATOR

Manual placebo hand held NB-UVB unit

Device: 311 nm NB-UVB light

Interventions

311 nm NB-UVB light DEVICE

Narrowband UVB is now the most common form of phototherapy used to treat skin diseases. Narrow-band refers to a specific wavelength of ultraviolet (UV) radiation, 311 to 312 nm. Hospital NB-UVB usually involves whole body cabinets suitable for extensive, generalised vitiligo i.e. large or multiple lesions. Usually the whole body is exposed to the UVB for a short time (seconds to minutes). NB-UVB is also used in the treatment of many other skin conditions including psoriasis and eczema. Hand held phototherapy units use the same lamp as the whole body units (TLO1) but only suitable for the treatment of smaller areas of skin i.e. early and focal lesions of vitiligo. Early reports showed that these units are also safe and effective for the treatment of psoriasis of the scalp.

Also known as: NB-UVB UV NB 311 UVTLO1

Dermfix 1000 active 311 nm NB-UVB; Dermfix 1000 placebo; Waldmann active 311 nm NB-UVB

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (2)

Queens Medical Centre,Nottingham University Hospitals NHS Trust

Nottingham, East Midlands, NG7 2UH, United Kingdom

Location

Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Related Publications (5)

• Whitton ME, Pinart M, Batchelor J, Lushey C, Leonardi-Bee J, Gonzalez U. Interventions for vitiligo. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003263. doi: 10.1002/14651858.CD003263.pub4.

  PMID: 20091542 BACKGROUND

• Gonzalez U, Whitton M, Eleftheriadou V, Pinart M, Batchelor J, Leonardi-Bee J. Guidelines for designing and reporting clinical trials in vitiligo. Arch Dermatol. 2011 Dec;147(12):1428-36. doi: 10.1001/archdermatol.2011.235. Epub 2011 Aug 15.

  PMID: 21844427 BACKGROUND

• Gawkrodger DJ, Ormerod AD, Shaw L, Mauri-Sole I, Whitton ME, Watts MJ, Anstey AV, Ingham J, Young K. Vitiligo: concise evidence based guidelines on diagnosis and management. Postgrad Med J. 2010 Aug;86(1018):466-71. doi: 10.1136/pgmj.2009.093278.

  PMID: 20709768 BACKGROUND

• Eleftheriadou V, Whitton ME, Gawkrodger DJ, Batchelor J, Corne J, Lamb B, Ersser S, Ravenscroft J, Thomas KS; vitiligo priority setting partnership. Future research into the treatment of vitiligo: where should our priorities lie? Results of the vitiligo priority setting partnership. Br J Dermatol. 2011 Mar;164(3):530-6. doi: 10.1111/j.1365-2133.2010.10160.x. Epub 2011 Jan 28.

  PMID: 21128908 BACKGROUND

• Eleftheriadou V, Thomas K, Ravenscroft J, Whitton M, Batchelor J, Williams H. Feasibility, double-blind, randomised, placebo-controlled, multi-centre trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home (HI-Light trial: Home Intervention of Light therapy). Trials. 2014 Feb 8;15:51. doi: 10.1186/1745-6215-15-51.

  PMID: 24507484 DERIVED

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hywel C. Williams, MSc PhD FRCP

  Centre of Evidence Based Dermatology

  STUDY CHAIR

• Viktoria Eleftheriadou, MD

  Centre of Evidence Based Dermatology

  STUDY DIRECTOR

• Jane C Ravenscroft, MB ChB, MRCP

  Queen's Medical Center

  PRINCIPAL INVESTIGATOR

• Anton Alexandroff, PhD MRCP

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 23, 2011
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: April 1, 2013
• Last Updated: August 23, 2013

Record last verified: 2013-08

Locations

GB (2)