Pilot Randomised Controlled Trial of Hand Held NB-UVB for the Treatment of Focal or Early Vitiligo at Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Proportion of eligible participants, willing to be randomised.
研究概览
简要总结
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
详细描述
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:
- To establish the proportion of eligible participants and their willingness to be randomised to home NB-UVB
Secondarily: 2. To establish participants' adherence and satisfaction in using home phototherapy 3. To assess success of blinding of both participants and outcome assessors by using an identical placebo unit with visible light fluorescence bulb instead of NB-UVB bulb. 4. To establish possible short term side effects i.e. if the device is suitable for home use with limited medical supervision 5. To manualise the treatment intervention, i.e. prepare package educating participants in how to use the intervention and to deal with possible side effects. 6. To define and test the primary and secondary outcome measures and the methods of data collection for the main RCT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Proportion of eligible participants, willing to be randomised.
时间窗: 4 to 6 months
To establish the proportion of eligible participants and their willingness to be randomised to home NB-UVB
次要结局
- 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)
- Incidence of NB-UVB short term adverse events(4 months)
- 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.(4 months)