HI-Light Vitiligo Trial: home interventions and light therapy for the treatment of vitiligo

Phase 1

• Conditions: Vitiligo; MedDRA version: 17.1Level: PTClassification code 10047642Term: VitiligoSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-003473-42-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-27
• Study Completion: 2019-12-01
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• 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).

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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).

9. Current participation in another clinical trial or intervention study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified