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

NCT ID: NCT01402414

Last Updated: 2014-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-02-28

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NB-UVB

NB-UVB irradiations adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session.

Group Type: ACTIVE_COMPARATOR

NB-UVB

Intervention Type: RADIATION

The SB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the SB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks.

Bath-PUVA

Phototherapy with UVA irradiation following bathing in psoralen water

Group Type: ACTIVE_COMPARATOR

Bath-PUVA

Intervention Type: RADIATION

Bath PUVA is performed with 8-Methoxypsoralen baths (concentration of ultimately 0.5 mg / l ) at 37 ° C with a bath time of 20 minutes and subsequent UVA irradiation (Waldmann cabine, 320-400 nm). The first dose is 70% of MPD, followed by 20% increase. The latter takes place at the earliest after 72 hours. The UV irradiations are carried out four times a week over a period of 4 weeks.

NB-UVB plus salt water baths

Balneophototherapy with NB-UVB and 3% Dead Sea salt water baths

Group Type: ACTIVE_COMPARATOR

NB-UVB plus salt water baths

Intervention Type: RADIATION

First, a 20-minute bath in 3% salt water (Dead Sea salt, 37 ° C) is taken. Thereafter, a NB-UVB irradiation is performed. The UV radiation can be administered according to established protocols. The NB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks.

Interventions

NB-UVB

The SB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the SB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks.

Intervention Type: RADIATION

Bath-PUVA

Bath PUVA is performed with 8-Methoxypsoralen baths (concentration of ultimately 0.5 mg / l ) at 37 ° C with a bath time of 20 minutes and subsequent UVA irradiation (Waldmann cabine, 320-400 nm). The first dose is 70% of MPD, followed by 20% increase. The latter takes place at the earliest after 72 hours. The UV irradiations are carried out four times a week over a period of 4 weeks.

Intervention Type: RADIATION

NB-UVB plus salt water baths

First, a 20-minute bath in 3% salt water (Dead Sea salt, 37 ° C) is taken. Thereafter, a NB-UVB irradiation is performed. The UV radiation can be administered according to established protocols. The NB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Sarah Terras

Thilo Gambichler, Professor, Ruhr University Bochum

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thilo Gambichler, adjunct professor

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum

Locations

Department of Dermatology, Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

RUB-126

Identifier Type: -

Identifier Source: org_study_id