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

This study has been terminated.
(Difficulties with the Recruitement)
Sponsor:
Information provided by (Responsible Party):
Sarah Terras, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01402414
First received: July 19, 2011
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Radiation: NB-UVB
Radiation: Bath-PUVA
Radiation: NB-UVB plus salt water baths

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Study Comparing the Effectiveness of Narrow-band UVB vs. Bath-PUVA and Narrow-band UVB + Salt Water Baths in Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Clinical improvement after treatments using a validated SASSAD index [ Time Frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up ] [ Designated as safety issue: No ]
    Clinical improvement after treatments using a validated SASSAD index


Secondary Outcome Measures:
  • Evaluation of pruritus and sleeplessness visual analogue scales [ Time Frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up ] [ Designated as safety issue: No ]
    Measuring patient's satisfaction / safety and quality of life using a qualified questionnaire: the Skindex-29.

  • Immunohistochemical, RT-PCR and serological parameters [ Time Frame: Evaluation at baseline and after 4-week treatment ] [ Designated as safety issue: No ]
    Measuring several immunohistochemical, RT-PCR and serological parameters in skin and blood, respectively.


Enrollment: 10
Study Start Date: April 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NB-UVB
NB-UVB irradiations adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session.
Radiation: 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.
Active Comparator: Bath-PUVA
Phototherapy with UVA irradiation following bathing in psoralen water
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.
Active Comparator: NB-UVB plus salt water baths
Balneophototherapy with NB-UVB and 3% Dead Sea salt water baths
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402414

Locations
Germany
Department of Dermatology, Ruhr University Bochum
Bochum, NRW, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Thilo Gambichler, adjunct professor Ruhr University Bochum
  More Information

No publications provided

Responsible Party: Sarah Terras, Thilo Gambichler, Professor, Ruhr University Bochum, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01402414     History of Changes
Other Study ID Numbers: RUB-126
Study First Received: July 19, 2011
Last Updated: February 20, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
atopic dermatitis
NB-UVB
phototherapy
balneophototherapy
Bath-PUVA
SCORAD index

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014