- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01787695
UVA 1 Phototherapy for Vitiligo
Aperçu de l'étude
Description détaillée
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.
There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Narrow-band UVB (NB-UVB) is currently the preferred treatment over topical psoralen and ultraviolet A radiation (PUVA), for patients with vitiligo. However, overall response of vitiligo to NB-UVB has been variable. Ultraviolet A1(UVA1) phototherapy is now useful for a variety of skin diseases, specifically scleroderma. There are only a few studies published on the efficacy of UVA1 in vitiligo.
One of the main side effects of UVA1 is prominent tanning which might be due to melanocyte stimulation. Therefore, the investigators hypothesis is that UVA1 will induce significant skin pigmentation to improve vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.
Study Objectives
- To evaluate the potential for UVA1 to induce repigmentation within vitiligo patches.
- To assess the side effect profile of UVA1 when used in the treatment of vitiligo.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E8
- Recrutement
- The Skin Care Center, Vancouver General Hospital
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Chercheur principal:
- Harvey Lui, MD FRCPC
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Contact:
- Harvey I Lui, MD FRCPC
- Numéro de téléphone: 68691 16048754111
- E-mail: harvey.lui@ubc.ca
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age > 18 years.
- Localized or generalized vitiligo that involves a non mucosal or acral site.
- Patients should have a patch of at least 25 cm2 that shows no more than 10% repigmentation as assessed visually
Exclusion Criteria:
- Patients who received treatment for vitiligo within the past 3 weeks.
- Patients known to have a photosensitivity disorder
- History of previous skin cancer.
- History of severe medical illness or immunosuppression.
- Pregnancy or breast-feeding.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Aucun traitement (couvert)
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Comparateur actif: UVA1
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Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into two halves. One half will be shielded by foil and served as control while the other half will be exposed to UVA1. The dose of UVA1 will be 60 J/cm2, 5 times a week for 4 weeks. Patients that have no or less than 10% pigmentation change after 4 weeks will receive UVA1 130J/cm2, 5 times a week for another 4 weeks. The patients with more than 10% pigmentation change will receive UVA1 60 J/cm2, 5times a week for another 4weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Change in the modified VASI score compared to baseline.
Délai: assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
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assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption
Délai: assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
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assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Harvey Lui, MD, FRCPC, University of British Columbia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H10-02235
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Vitiligo
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PfizerRecrutementVitiligo non segmentaire stable | Vitiligo actif non segmentaireÉtats-Unis, Espagne, Australie, Mexique, Canada, Chine, Japon, Italie, Turquie, Corée, République de, Allemagne, Afrique du Sud, Pologne, Royaume-Uni, Bulgarie
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PfizerRecrutementVitiligo non segmentaire stable | Vitiligo actif non segmentaireChine, Japon, Canada, Espagne, États-Unis, Hongrie, Pologne, Slovaquie
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Fundació Institut de Recerca de l'Hospital de la...Complété
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Cairo UniversitySuspendu
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Assiut UniversityInconnue
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University of TorontoCanadian Interdisciplinary Network Complementary & Alternative Medicine...Complété
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University Hospital, GhentNovartisComplétéVitiligo vulgaireBelgique
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Incyte CorporationRecrutementVitiligo non segmentaireAllemagne, États-Unis, Italie, Pologne, Canada, France, Bulgarie, Hongrie, Royaume-Uni
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Merck Sharp & Dohme LLCRecrutementVitiligo non segmentaireÉtats-Unis, Canada, Australie, Corée, République de, Suisse, Allemagne, Espagne, Chili, France, Israël, Pays-Bas, Japon, Belgique
Essais cliniques sur UVA1
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Ben ChongDaavlin CorporationComplétéLupus érythémateux cutanéÉtats-Unis
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University of MichiganRésiliéPsoriasis | Mycose fongoïde | La dermatite atopique | Alopécie | Urticaire | Vergetures | DermatosesÉtats-Unis
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Ruhr University of BochumComplétéLa dermatite atopiqueAllemagne
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Nicolas HunzelmannUniversity Hospital TuebingenRésiliéSclérodermie systémique | Sclérodermie systémiqueAllemagne
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University of MichiganRésiliéCicatrices | Chéloïde | Sclérodermie | Granulome annulaire | Acné Keloidalis NuchaeÉtats-Unis
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University of DundeeNHS TaysideComplétéEczéma atopiqueRoyaume-Uni
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Cairo UniversityInconnueSclérodermie localiséeEgypte
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Henry Ford Health SystemActif, ne recrute pasEn bonne santéÉtats-Unis
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University of MichiganComplétéSclérodermie | Chéloïdes | Autres conditions fibrosantesÉtats-Unis
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Medical University of ViennaComplété