Clinical trial NCT01402414: Narrow-band (NB)-UVB vs. Bath-PUVA and NB-UVB Plus Salt Water Baths in Atopic Dermatitis
Official title: Study Comparing the Effectiveness of Narrow-band UVB vs. Bath-PUVA and Narrow-band UVB + Salt Water Baths in Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
NB-UVB
phototherapy
balneophototherapy
Bath-PUVA
SCORAD index
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe disease AD with SASSAD-Score \> 25
* Age \> 18 years
* No topical steroids or topical/systemic antibiotics within the last 2 weeks, no systemic glucocorticosteroids or other immunosuppressive agents within the last 8 weeks, no phototherapy within the last 12 weeks before inclusion

Exclusion Criteria:

* Pregnancy or lactation
* Skin cancer or dysplastic naevi, photosensitive skin diseases, autoimmune diseases or relevant cardiovascular diseases
* Photo-skin type I according to Fitzpatrick
* severe cardiovascular disease
* intense UV radiation (tanning beds, sun exposure, phototherapy, etc.) 8 weeks before the start of the study

Primary outcomes:
measure: Clinical improvement after treatments using a validated SASSAD index
timeFrame: Evaluation at baseline and after 4-week treatment, 3 months follow-up
Secondary outcomes:
measure: Evaluation of pruritus and sleeplessness visual analogue scales
timeFrame: Evaluation at baseline and after 4-week treatment, 3 months follow-up
measure: Measuring quality of life using the Skindex-29
timeFrame: Evaluation at baseline and after 4-week treatment, 3 months follow-up
measure: Immunohistochemical, RT-PCR and serological parameters
timeFrame: Evaluation at baseline and after 4-week treatment
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Ruhr University Bochum
state: NRW
Study officials:
affiliation: Ruhr University Bochum
name: Thilo Gambichler, adjunct professor
role: PRINCIPAL_INVESTIGATOR
References: