Home interventions and light therapy for the treatment of vitiligo
| ISRCTN | ISRCTN17160087 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17160087 |
| EudraCT/CTIS number | 2014-003473-42 |
| Secondary identifying numbers | 17720; HTA 12/24/02 |
- Submission date
- 08/01/2015
- Registration date
- 08/01/2015
- Last edited
- 09/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Vitiligo is a common skin disorder affecting about 1% of the world’s population, regardless of age, sex or skin colour. Vitiligo causes white patches on the skin, which can spread to cover large areas of the body. It is more noticeable on dark or tanned skin, causing people with vitiligo to be stigmatised in some communities. Vitiligo can cause feelings of panic, depression and despair. Although vitiligo is not fatal, it can have a devastating effect on the quality of life of those who have it, particularly if it affects visible sites such as the face and hands. Children can experience teasing and bullying as a result of having the disease and many adults report a lack of confidence, poor self-esteem and an inability to form relationships. Current treatments for vitiligo are limited. They seldom restore natural skin colour to all the white patches and do not prevent the disease from coming back. In the early stages of the disease the use of corticosteroid creams or other ointments can sometimes be successful. GPs are often unaware of the psycho-social effects of vitiligo and in the absence of treatments specifically licensed for vitiligo may offer no help to the patient apart from special make-up to cover up the white patches. Light treatment prescribed for extensive vitiligo can work for some, but requires prolonged and frequent visits to hospital. Hand-held NB-UVB light units are available to use in the home on small patches of vitiligo. However, these units are not available on the NHS. There is not a lot of information about how well steroid creams and light therapy work to improve the appearance of vitiligo, and we do not know whether they would work, or work better, together. The aim of this study is to find out more information about how well the treatments work, and to find out if they work, or work better, when used together.
Who can participate?
Children aged 5 years and over and adults with active vitiligo (new or spreading patches) that affects less than 10% of their body
What does the study involve?
Participants are randomly allocated to receive either light therapy plus a placebo (dummy) ointment, or a steroid ointment plus placebo (dummy) light therapy, or a combination of steroid ointment and light therapy. The light therapy is delivered using a small hand held light therapy device used three times a week, and the ointment is applied to the skin once daily on a 'one week on, one week off' basis. The light therapy device is easy to use and has a spacer to avoid the light getting too close to the skin. There are also safety goggles to protect the eyes from the light. The participants are interviewed beforehand, given a leaflet to explain the study, and are shown a training video on how to use the treatments. They are asked to use a diary to record their treatment sessions and any side effects. They are supervised by a research nurse, and are able to contact the study team should there be any problems with the treatment. Participants receive treatment for 9 months and their response to treatment is assessed in clinic every 3 months. At the end of the treatment period participants are followed-up for a further 12 months so that the long-term response to treatment can be checked.
What are the possible benefits and risks of participating?
This study could add to the choice of treatments available for people with vitiligo, many of whom receive no treatment at all. Should the study prove to be a success, it could make a big difference to the lives of many people who have not had much help for what has often been considered a trivial, cosmetic condition. By giving people with vitiligo the opportunity to treat themselves or their children at home, participants avoid the inconvenience of having to attend hospital two or three times a week for light therapy. There is also the possibility that early treatment of small vitiligo areas could mean shorter treatment periods and better treatment response. The burden of participation in the study is low and the risks are small. Both of the compared treatments are recommended for the treatment of vitiligo and are appropriate for both children and adults. One possible side effect of the light therapy is burns, but clear instructions as to how to distinguish burns from just a reddening of the skin will be given and treatment can be adjusted accordingly.
Where is the study run from?
The study takes place in about 16 hospitals in the UK, and is co-ordinated from the Nottingham Clinical Trials Unit in collaboration with the Centre of Evidence Based Dermatology.
When is the study starting and how long is it expected to run for?
May 2015 to October 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Rachel Haines
Contact information
Scientific
Nottingham Clinical Trials Unit
Nottingham Health Science Partners
Room 2201
C Floor
South Block Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Can be found at: http://www.vitiligostudy.org.uk/ |
| Scientific title | Home interventions and light therapy for the treatment of vitiligo |
| Study acronym | HI-Light Vitiligo |
| Study hypothesis | The HI-Light trial has been designed to test two commonly used treatments: topical steroid ointment and NB-UVB light therapy. The trial aims to find out more information about how well the treatments work, and to find out if they work, or work better, when used together. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/122402 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/130657/PRO-12-24-02.pdf |
| Ethics approval(s) | 14/EM/1173; First MREC approval date 27/10/2014 |
| Condition | Vitiligo |
| Intervention | Participants will be asked to treat their vitiligo patches at home for a period of 9 months. Participants will be allocated to three groups: 1. NB-UVB light therapy (Dermfix Model 1000MX) plus placebo ointment (white soft paraffin) 2. Placebo NB-UVB light therapy (Dermfix 1000MX with no NB-UVB output) plus potent topical corticosteroid ointment (Mometasone Furoate 0.1% [Elocon]) 3. NB-UVB light therapy (Dermfix Model 1000MX) plus potent topical corticosteroid ointment (Mometasone Furoate 0.1% [Elocon]) |
| Intervention type | Mixed |
| Primary outcome measure | Patient-reported treatment success based on vitiligo noticeability scale at target lesion; Timepoint(s): 9 months |
| Secondary outcome measures | Current secondary outcome measures as of 24/07/2019: 1. Adverse events and adverse device effects; Timepoint(s): 3, 6, 9 months. 2. Cost-effectiveness; Timepoint(s): 21 months. 3. Investigator assessed onset of treatment response (including cessation of spread); Timepoint(s): 3, 6, 9 months. 4. Investigator assessed percentage of repigmentation; Timepoint(s): 3, 6, 9 months. Assessed by digital image at 9 months. 5. Patient reported Maintenance of Repigmentation (3 lesions); Timepoint(s): 12, 15, 18 ,21 months. 6. Patient reported treatment success based on vitiligo noticeability scale at three body sites; Timepoint(s): 3, 6, 9 months. 7. Quality of Life measures; Timepoint(s): 9 and 21 months. 8. VNS treatment success by blinded review of digital images at 9 months. Previous secondary outcome measures: 1. Adverse events and adverse device effects; Timepoint(s): 3, 6, 9 months 2. Cost-effectiveness; Timepoint(s): 21 months 3. Investigator assessed onset of treatment response (including cessation of spread); Timepoint(s): 3, 6, 9 months 4. Investigator assessed percentage of repigmentation; Timepoint(s): 3, 6, 9 months 5. Reassessed by digital image at 9 months 6. Patient reported Maintenance of Repigmentation (3 lesions); Timepoint(s): 12, 15, 18 ,21 months 7. Patient reported treatment success based on vitiligo noticeability scale at three body sites; Timepoint(s): 3, 6, 9 months 8. Quality of Life measures; Timepoint(s): 9 and 21 months |
| Overall study start date | 01/05/2015 |
| Overall study end date | 01/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 516; UK Sample Size: 516; Description: Standard care is assumed to be topical corticosteroid used as monotherapy and so ‘topical corticosteroid plus dummy light therapy’ is the comparator group for all treatment comparisonsThere are two comparisons of primary interest: I. NB-UVB light therapy (plus placebo ointment) compared to topical corticosteroids (plus dummy light) II. Combination of NB-UVB light therapy and topical corticosteroids compared to topical corticosteroids (plus dummy light). |
| Total final enrolment | 517 |
| Participant inclusion criteria | 1. Patients 5 years of age or over with a diagnosis of non-segmental vitiligo confirmed by a dermatologist 2. Vitiligo limited to less than 10% of body surface area, with at least one patch that is reported by the participant to have been active (new onset or spread) in the last 12 months 3. No other active therapy for vitiligo (or willing to stop current treatment – no washout period required) 4. Able to administer the intervention safely at home 5. Able and willing to give informed consent (or parental/guardian consent in the case of children) |
| Participant exclusion criteria | 1. Other types of vitiligo (e.g. segmental or universal vitiligo) 2. Patients with vitiligo limited to areas of the body for which NB-UVB light therapy or potent topical corticosteroids would be inappropriate (e.g. around the genitals) 3. History of skin cancer (ever) 4. History of radiotherapy use (ever) 5. Photosensitivity (e.g. lupus, polymorphic light eruption, solar urticaria, chronic actinic dermatitis, actinic prurigo, porphyria or other photosensitivity disorders e.g. dermatomyositis) 6. Pregnant, breastfeeding or likely to become pregnant during the 9-month treatment period 7. Current use of immunosuppressive drugs (e.g. e.g. ciclosporin, azathioprine, mycophenolate mofetil, methotrexate, systemic tacrolimus) 8. Allergy or contraindication to mometasone furoate or any of its components (e.g any cutaneous bacterial, viral or fungal infections in the area to be exposed to trial treatments), as listed in section 4.3 of the SmPC 9. Current participation in another clinical trial or intervention study |
| Recruitment start date | 01/05/2015 |
| Recruitment end date | 31/08/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Room 2201
C Floor
South Block Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Hospital/treatment centre
Academic Division of Obstetrics and Gynaecology
Nottingham
NG7 2UH
England
United Kingdom
"ROR" |
https://ror.org/01ee9ar58 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets analysed during the current study will be available upon request from the NCTU (ctu@nottingham.ac.uk), a minimum of 6 months after publication of the main results paper. Access to the data will be subject to review of a data sharing and use request by a committee including the CI and sponsor, and will only be granted upon receipt of a data sharing and use agreement. Any data shared will be pseudoanonymised which may impact on the reproducilbilty of published analyses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/04/2018 | Yes | No | |
| Other publications | QA and characterisation of home UV devices | 01/10/2020 | 28/10/2020 | Yes | No |
| Results article | results | 01/11/2020 | 30/11/2020 | Yes | No |
| Other publications | Economic evaluation | 04/11/2020 | 09/02/2023 | Yes | No |
| Other publications | Nested process evaluation | 30/05/2022 | 09/02/2023 | Yes | No |
| Results article | 28/12/2020 | 09/02/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/02/2023: Publication references added.
30/11/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
28/10/2020: Publication reference added.
24/07/2019: The secondary outcome measures were updated.
19/12/2018: The following changes were made to the trial record:
1. The publication and dissemination plan was added.
2. The intention to publish date was changed from 01/08/2019 to 01/07/2020.
3. The participant level data was added.
18/09/2018: The overall trial end date was updated from 31/07/2017 to 01/07/2019.
06/04/2018: Publication reference added.
12/05/2017: The recruitment end date has been changed from 28/02/2017 to 31/08/2017 and the target number of participants has been updated from 440 to 516
07/11/2016: The recruitment end date has been changed from 31/10/2016 to 28/02/2017
09/06/2016: Plain English summary added.
