Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases

  • STATUS
    Recruiting
  • End date
    Oct 21, 2022
  • participants needed
    240
  • sponsor
    Medical University of Graz
Updated on 21 January 2021
skin disorder
chemotherapy regimen
extracorporeal photopheresis
puva
psoralen

Summary

The molecular mechanisms of action of photo(chemo)therapy in skin diseases are investigated in this study. The phototherapeutic modalities employed include UVB (ultraviolet B), UVA (ultraviolet A), PUVA (psoralen+UVA) and/or extracorporeal photochemotherapy (photopheresis). The study will address whether and how photo(chemo)therapy affects specific biologic pathways in different skin disorders and search for predictive biomarkers.

Description

This study is performed in order to investigate the molecular mechanisms of action of photo(chemo)therapy in skin diseases, including psoriasis, cutaneous T-cell lymphoma, other lymphoproliferative disorders of the skin, eczema, lichen planus, prurigo/pruritus, polymorphic light eruption, mastocytosis, graft-versus-host disease, vitiligo and other photo(chemo)therapy-responsive diseases. Twenty patients will be enrolled per diagnosis group. The phototherapeutic modalities administered will be UVB, UVA, PUVA and/or extracorporeal photochemotherapy (photopheresis). The severity of disease and clinical response to treatment will be assessed with scores including dermatological quality of life (DLQI) and disease-specific scores such as PASI (psoriasis area and severity index), mSWAT (modified severity-weighted assessment tool), SCORAD (scoring atopic dermatitis), scleroderma score and/or different visual analog scale (VAS) scores for pruritus. The effect of treatment on a variety of laboratory endpoints will be investigated in blood samples and optionally also skin samples. Those endpoints include among others the regulation of cytokines/chemokines, immune function, clonality of immune cells, vitamin D, and serum lipids. The study will address whether and how photo(chemo)therapy affects specific biologic pathways in the different disorders and determine whether predictive biomarkers for therapeutic response exist.

Details
Condition Pruritus, Prurigo, Eczema, Psoriasis, Graft-Versus-Host Disease, Lichen Planus, cutaneous T-cell lymphoma, Dermatosis, Urticaria Pigmentosa, Dermatitis, Mastocytosis, Lymphoproliferative Disorder, T-Cell Lymphoma, Vitiligo, Psoriasis and Psoriatic Disorders, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Congenital Skin Diseases, Graft-Versus-Host Disease (GVHD), Prurigo Nodularis, Skin Conditions, Lymphoproliferative disorders, graft versus host disease, lymphoproliferative disease, graft-versus-host-disease, Polymorphic Light Eruption
Treatment Photo(chemo)therapy
Clinical Study IdentifierNCT03340155
SponsorMedical University of Graz
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > 18 years
Skin disorder to be treated with photo(chemo)therapy

Exclusion Criteria

Pregnancy and breastfeeding
Poor general health status
Clear my responses

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