Topical Psoralen Ultraviolet Light A Versus Narrow Band Ultraviolet Light B Treatment for Recalcitrant Dermatoses of the Hand
Topical Psoralen Ultraviolet Light A Versus Narrow Band Ultraviolet Light B Treatment for Recalcitrant Dermatoses of the Hand: A Prospective Randomized, Single-blinded Controlled Clinical Trial
Przegląd badań
Szczegółowy opis
Hand dermatoses is a common problem which is characterized by itchy, erythematous and scaly lesions often with a long lasting and relapsing course. Patients presenting with these severe cutaneous changes are classified as having severe recalcitrant hand dermatoses. Treatment is difficult with considerable number of patients do not or only partially respond to the current treatments. Current treatment regimens mainly involve the use of high potency topical corticosteroids, which has only limited affect. Systemic treatment modalities have been utilized but have serious side effects with limited improvement of disease.
Several studies have shown the therapeutic effectiveness of the combination of topical psoralen with long wavelength ultraviolet A radiation (PUVA) in treating hand dermatoses. Topical PUVA is commonly associated with mild local sunburn reactions that often necessitate temporarily withholding treatment or decreasing the light dose. This subsequently leads to a delay in response or a prolongation of the treatment. Long term side effects include aging of the skin, hyperpigmentation, and a small increased risk of skin cancer that is more common in systemic PUVA. Narrow band ultraviolet B (NB-UVB) has emerged recently as an important treatment for a variety of photoresponsive diseases including psoriasis and eczema. For most conditions (other than hand psoriasis/eczema) NB-UVB has been shown to have similar therapeutic results to PUVA with less side effects.
There are only a few studies published on the efficacy of NB-UVB for hand psoriasis/eczema. Our hypothesis is that NB-UVB and topical PUVA will result in at least comparable improvement in hand psoriasis/eczema with less side effects associated with NB-UVB. We plan on conducting a prospective single-blind randomized clinical trial to compare the efficacy and safety of topical PUVA and NB-UVB in treating hand psoriasis/eczema.
Study Objectives
- To compare the effect of topical PUVA and NB-UVB on visual cutaneous symptoms in patients presenting with recalcitrant hand dermatoses.
- To compare the side effect profile of topical PUVA and NB-UVB when treating patients with recalcitrant hand dermatoses.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 4E8
- Rekrutacyjny
- The Skin Care Center, Vancouver General Hospital
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Kontakt:
- Harvey Lui, MD FRCPC
- Numer telefonu: 16048754111
- E-mail: harvey.lui@ubc.ca
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Główny śledczy:
- Sunil Kalia, MD FRCPC
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Chronic symmetrical severe hand psoriasis and eczema (allowing up to 15% difference in surface area between both hands). These include patients that have received topical corticosteroids previously and may or may have not responded to treatment.
- Subjects should be 18 years old or older.
Exclusion Criteria:
- Any serious medical illness that will restrict the patient's ability to receive light treatments. That includes skin conditions, such as skin cancer or severe blistering conditions, or any serious medical conditions affecting the sensation of the extremities (eg. diabetic neuropathy, cervical stenosis).
- Patients known to have a photosensitivity disorder
- Patients with a history of intolerance to UVB and/or UVA light therapy.
- Any subject who is on treatment or was on treatment for hand psoriasis/eczema less than two (topical) or four (systemic/phototherapy) weeks prior to enrollment in the study.
- Pregnancy or breast-feeding.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: NB-UVB
This single-blinded randomized bilateral left to right controlled comparison clinical trial of 24 weeks duration will compare the efficacy of NB-UVB to t-PUVA.
For each patient one hand will be randomly assigned to receive t-PUVA and the other hand will receive NB-UVB.
Each hand will receive treatment with either NB-UVB or topical PUVA three times weekly.
Treatment will be performed until complete or almost complete clearing of psoriasis/eczema or until 50 exposures (over 16 weeks) have been reached, whichever comes first.
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Aktywny komparator: Topical PUVA
This single-blinded randomized bilateral left to right controlled comparison clinical trial of 24 weeks duration will compare the efficacy of NB-UVB to t-PUVA.
For each patient one hand will be randomly assigned to receive t-PUVA and the other hand will receive NB-UVB.
Each hand will receive treatment with either NB-UVB or topical PUVA three times weekly.
Treatment will be performed until complete or almost complete clearing of psoriasis/eczema or until 50 exposures (over 16 weeks) have been reached, whichever comes first.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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The primary endpoint will be based on the change in visual cutaneous symptoms as measured by the modified ASI score
Ramy czasowe: Baseline, every four weeks up to 16 weeks, and at 24 weeks
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Baseline, every four weeks up to 16 weeks, and at 24 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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The overall change in physical appearance of the hand will be assessed by the global assessment
Ramy czasowe: Every four weeks up to 16 weeks, and at 24 weeks
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Every four weeks up to 16 weeks, and at 24 weeks
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Adverse effects will be assessed every four weeks, including erythema, pruritus, and tanning. This will be assessed using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
Ramy czasowe: Every four weeks up to 16 weeks
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Every four weeks up to 16 weeks
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Harvey Lui, MD, FRCPC, University of British Columbia
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- H12-02854
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