EUCTR2014-003473-42-GB
Active, not recruiting
Phase 1
Home Interventions and Light therapy for the treatment of vitiligo - HI-Light Vitiligo Trial
niversity of Nottingham0 sites517 target enrollmentMarch 27, 2015
ConditionsVitiligoMedDRA version: 17.1Level: PTClassification code 10047642Term: VitiligoSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsElocon
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Vitiligo
- Sponsor
- niversity of Nottingham
- Enrollment
- 517
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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).
- •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
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
Outcomes
Primary Outcomes
Not specified
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