Vitiligo Skin and Connective Tissue Diseases Vitiligo
Conditions
Interventions
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 1000
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported treatment success based on vitiligo noticeability scale at target lesion; Timepoint(s): 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed