NCT01402414

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

July 19, 2011

Last Update Submit

February 20, 2014

Conditions

Atopic Dermatitis

Keywords

atopic dermatitisNB-UVBphototherapybalneophototherapyBath-PUVASCORAD index

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement after treatments using a validated SASSAD index

    Clinical improvement after treatments using a validated SASSAD index

    Evaluation at baseline and after 4-week treatment, 3 months follow-up

Secondary Outcomes (3)

  • Evaluation of pruritus and sleeplessness visual analogue scales

    Evaluation at baseline and after 4-week treatment, 3 months follow-up

  • Measuring quality of life using the Skindex-29

    Evaluation at baseline and after 4-week treatment, 3 months follow-up

  • Immunohistochemical, RT-PCR and serological parameters

    Evaluation at baseline and after 4-week treatment

Study Arms (3)

NB-UVB

ACTIVE COMPARATOR

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

Radiation: NB-UVB

Bath-PUVA

ACTIVE COMPARATOR

Phototherapy with UVA irradiation following bathing in psoralen water

Radiation: Bath-PUVA

NB-UVB plus salt water baths

ACTIVE COMPARATOR

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

Radiation: NB-UVB plus salt water baths

Interventions

NB-UVBRADIATION

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.

NB-UVB
Bath-PUVARADIATION

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.

Bath-PUVA
NB-UVB plus salt water bathsRADIATION

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.

NB-UVB plus salt water baths

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate to severe disease AD with SASSAD-Score \> 25
  • Age \> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Thilo Gambichler, adjunct professor

    Ruhr University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thilo Gambichler, Professor, Ruhr University Bochum

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 26, 2011

Study Start

April 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 21, 2014

Record last verified: 2014-02

Locations

DE(1)