HI-Light Pilot Trial for Vitiligo: Hand Held NB-UVB for Early or Focal Vitiligo at Home (HI-Light)
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|ClinicalTrials.gov Identifier: NCT01478945|
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : August 23, 2013
|First Submitted Date ICMJE||November 15, 2011|
|First Posted Date ICMJE||November 23, 2011|
|Last Update Posted Date||August 23, 2013|
|Study Start Date ICMJE||February 2012|
|Actual Primary Completion Date||September 2012 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Proportion of eligible participants, willing to be randomised. [ Time Frame: 4 to 6 months ]
To establish the proportion of eligible participants and their willingness to be randomised to home NB-UVB
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||HI-Light Pilot Trial for Vitiligo: Hand Held NB-UVB for Early or Focal Vitiligo at Home|
|Official Title ICMJE||Pilot Randomised Controlled Trial of Hand Held NB-UVB for the Treatment of Focal or Early Vitiligo at Home|
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
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:
Parallel groups-Three arms study
Participants will primarily be indentified in secondary care (Nottingham, Leicester, Derby and Mansfield) and by direct advertising. Recruitment will be extended to include primary care if time and resources allow.
Sample size estimate:
This is a pilot study, with sample size being resource driven in terms of available subjects in a reasonable time frame, for which no formal statistically based sample size estimate is applicable.
For this pilot study, 21 participants (7 in each group) will allow the investigators to measure the recruitment rate from each site; n=21 will also give a reasonable estimate of acceptability and completeness of outcome data.
Number of participants:
The investigators estimate to recruit 21 participants, 7 in each group; however the recruitment will depend on time and resources available.
Description of interventions:
The hand held NB-UVB unit is a portable and light weight NB-UVB device that is slightly larger than a usual hairbrush.
These units are CE marked and are being used within their licensing authorisations.
The hand held device is held above any small area of the skin (10-12cm x 6.5-4 cm) and spacers are provided in order to standardise the distance from the skin. Hand held NB-UVB units are suitable for small lesions making phototherapy available for participants with limited disease, and for participants who find it difficult to attend hospital-based phototherapy units 2 to 3 times a week.
The lamp is held still above the vitiliginous lesion. If the size of the lesion is bigger than mentioned above i.e. 10-12 cm X 6.5-4 cm, the participant (or their parent or legal guardian for younger participants) will be asked to move the lamp slowly above the area in circular movements.
In this trial the investigators will explore 2 similar hand held NB-UVB (311nm) phototherapy devices with the same output, but a slighly different size of treatment window, weight of the device and cable length. By doing this the investigators will be able to monitor and assess which of the 2 units is best tolerated in terms of participants' satisfaction and minimisation of side effects. The information gathered will assist in the choice of device for the main RCT.
Device A: Dermfix 1000 NB-UVB Device B: Waldmann UV 109 Both devices are manual units with an on/off switch and an external digital timer. The user of this device has to follow the written treatment protocol, set and re-set the timer each time manually and to keep an accurate diary of exposure times.
The devices need to be connected to a socket all the time.
Placebo Device: Placebo Dermfix 1000, same as Device A The placebo device to be used is identical to the active device Dermfix with the only difference that it will not emit 311nm NB-UVB.
Duration of study:
The recruitment is planned to commence as soon as approvals (ethics and R&D) are in place and should take approximately 6 months. Each participant will participate in the study for 4 months. Participants will be assessed at face to face visits at the beginning of the screening stage-baseline, 8th week and 16th week. Outcomes will be assessed at the same time points.
Follow up telephone calls will be made at weeks 1, 2 and 12.
Randomisation and blinding:
Participants will be blinded to which device they have received, (intervention groups A or B or control group C).
The research nurse will be blinded to which group the participants are allocated (intervention groupS A or B or control group C).
The randomisation will be based on a computer generated pseudo-random code using random permuted blocks of randomly varying size, created by the Nottingham Clinical Trials Unit (CTU) in accordance with their standard operating procedure (SOP) and held on a secure server. The randomisation will be stratified by 3 groups (Group A, B and C) and 2 recruiting sites.
Demographic, baseline data and measure of compliance will be summarised by descriptive statistics (number[n], mean, standard deviation [SD], median, minimum and maximum) or frequency tables, stratified by treatment.
Also, calculation of the re-pigmentation rate, spread & cessation of the vitiligo lesions will be conducted for all of the 3 devices. This information will be vital for the sample size calculation for the definitive trial.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
|Intervention ICMJE||Device: 311 nm NB-UVB light
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.
Other Name: NB-UVB UV NB 311 UVTLO1
|Study Arms ICMJE||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||April 2013|
|Actual Primary Completion Date||September 2012 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||5 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT01478945|
|Other Study ID Numbers ICMJE||11/EM/0331
PR-PG-040710177 ( Other Grant/Funding Number: NIHR "SPRUSD" grant )
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||University of Nottingham|
|Study Sponsor ICMJE||University of Nottingham|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of Nottingham|
|Verification Date||August 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP