Atopic Dermatitis Clinical Trial
Official title:
Study Comparing the Effectiveness of Narrow-band UVB vs. Bath-PUVA and Narrow-band UVB + Salt Water Baths in Atopic Dermatitis
In this controlled crossover study we aim to compare the efficacy of narrow-band UVB (NB-UVB) with bath-PUVA and NB-UVB plus salt water baths in atopic dermatitis.
Atopic dermatitis (AD) is a very common skin disorder that is characterized by pruritic
inflammatory skin lesions, with patients usually having an individual or family history of
atopic diseases in their background (e.g., allergic asthma and rhinitis). Defective skin
barrier, immunological dysfunctions (type I and IV allergy), genetic disorders, and
psychological factors contribute to the pathogenesis of AD. However, among these factors,
CD4+ Th cells are reported to play a particularly crucial role in the pathogenesis of AD.
Phototherapy is among the first-line approaches in the management of AD. In this context, a
variety of studies have shown a beneficial effect of natural or artificial UV radiation in
AD. Different broadband (BB) UV spectra (BB-UVA, BB-UVB, BB-UVA/BB-UVB) and combined
treatment modalities such as balneophototherapy and PUVA have previously been proven to be
effective in AD. A small controlled study has previously demonstrated that the combination
of UVB/UVA and saltwater baths is superior to phototherapy alone. Previous data from
uncontrolled studies also speak for the effectiveness of systemic psoralen plus UVA (PUVA)
therapy. A controlled crossover study has shown that systemic PUVA therapy is clearly
superior to UVA1 phototherapy both in terms of clinical score (SCORAD) and reduction of
response time. Systemic PUVA has in relation to bath PUVA significantly greater adverse
effects (eg, nausea, liver enzyme elevation, photocarcinogenesis). A direct comparison
between NB-UVB and bath PUVA has only been studied by a half-side comparison in a small
number of patients. Both therapies were proved equally effective. In a recent study, it has
been shown a clear advantage of NB-UVB plus salt water baths in comparison to NB-UVB alone.
Tolerability was comparable; both treatments showed to be safe.
A randomized observer-blinded controlled crossover trial is conducted in which patients with
AD receive a 4-week course of both NB-UVB and bath-PUVA or NB-UVB plus salt water baths.
Clinical efficacy is assessed using the Six Area, Six Sign, Atopic Dermatitis (SASSAD) score
and a visual analogue scale for pruritus. Assessment of health-related quality of life was
performed using the Skindex-29. Moreover, immunohistochemical, RT-PCR and serological
studies are planned.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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