Narrow-band (NB)-UVB vs. Bath-PUVA and NB-UVB Plus Salt Water Baths in Atopic Dermatitis

Not Applicable

Terminated

• Conditions: Atopic Dermatitis
• Interventions: Radiation: NB-UVB; Radiation: Bath-PUVA; Radiation: NB-UVB plus salt water baths

• Registration Number: NCT01402414
• Lead Sponsor: Ruhr University of Bochum

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NB-UVB	NB-UVB	NB-UVB irradiations adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session.
Bath-PUVA	Bath-PUVA	Phototherapy with UVA irradiation following bathing in psoralen water
NB-UVB plus salt water baths	NB-UVB plus salt water baths	Balneophototherapy with NB-UVB and 3% Dead Sea salt water baths

Primary Outcome Measures

Name	Time	Method
Clinical improvement after treatments using a validated SASSAD index	Evaluation at baseline and after 4-week treatment, 3 months follow-up	Clinical improvement after treatments using a validated SASSAD index

Secondary Outcome Measures

Name	Time	Method
Evaluation of pruritus and sleeplessness visual analogue scales	Evaluation at baseline and after 4-week treatment, 3 months follow-up	Evaluation of pruritus and sleeplessness using visual analogue scales with 0 being no complaints and 10 being the worst complaints imaginable
Measuring quality of life using the Skindex-29	Evaluation at baseline and after 4-week treatment, 3 months follow-up	Measuring patient's satisfaction / safety and quality of life using a qualified questionnaire: the Skindex-29.
Immunohistochemical, RT-PCR and serological parameters	Evaluation at baseline and after 4-week treatment	Measuring several immunohistochemical, RT-PCR and serological parameters in skin and blood, respectively.

Trial Locations

Locations (1)

Department of Dermatology, Ruhr University Bochum; 🇩🇪 Bochum, NRW, Germany