Home interventions and light therapy for the treatment of vitiligo

Not Applicable

Completed

• Conditions: Vitiligo; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN17160087
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29615444 protocol 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33107975/ QA and characterisation of home UV devices (added 28/10/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33245043/ results (added 30/11/2020) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32920824/ Economic evaluation (added 09/02/2023) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35340044/ Nested process evaluation (added 09/02/2023) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33006767/ (added 09/02/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-08
• Study Completion: 2019-07-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 517

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported treatment success based on vitiligo noticeability scale at target lesion; Timepoint(s): 9 months