NCT00533195

Brief Summary

The purpose of this study is to compare the efficacy, tolerability and remission duration of UVA 1 therapy versus 5-MOP UVA photochemotherapy for patients with severe generalized atopic dermatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

September 19, 2007

Last Update Submit

January 13, 2009

Conditions

Atopic Dermatitis

Keywords

UVA1PUVAatopic dermatitis

Outcome Measures

Primary Outcomes (1)

  • remission duration after UVA1 phototherapy and after 5-MOP UVA photochemotherapy

    12 months

Secondary Outcomes (1)

  • SCORAD Score at the end of therapy and at 1,3,6 and 12 months after therapy; total IgE and ECP values at the beginning and the end of therapy; cumulative UVA doses; side effects

    12 months

Study Arms (2)

0

ACTIVE COMPARATOR

5-MOP photochemotherapy. Intake of Geralen capsules (1.2 mg/kg) 2 hours before irradiation. Determination of the minimal phototoxic dose (MPD) and Geralen serum level prior to treatment. Start with 70 % of the MPD, no dose increments in the first treatment week. From the second week increments of the UVA dose by 20 % in the absence of an erythemal reaction, respectively by 10 % in cases of a barely perceptible erythemal response. Increments of the UVA dose at the earliest 96 hours after the last increments. Treatment frequency 3 x week for 5 weeks (=15 exposures). No maintenance therapy except emollients.

Drug: 5-Methoxypsoralen

1

EXPERIMENTAL

UVA1 phototherapy. Treatment 5 x week for 3 weeks (=15 irradiations). Determination of the UVA 1 MED prior to treatment. Start with 1 MED. Increments of the UVA 1 dose in 20 % steps until a maximal dose of 70 J/cm2 in the absence of an erythemal reaction and by good tolerability. No maintenance therapy except emollients.

Device: UVA1 phototherapy

Interventions

5-MethoxypsoralenDRUG

1,2 mg/kg 2 hours before UVA irradiation p.o. 3 times weekly for 5 weeks

Also known as: 5-MOP, Geralen
0
UVA1 phototherapyDEVICE

Treatment 5 x week for 3 weeks (=15 irradiations). Determination of the UVA 1 MED prior to treatment. Start with 1 MED. Increments of the UVA 1 dose in 20 % steps until a maximal dose of 70 J/cm2 in the absence of an erythemal reaction and by good tolerability. No maintenance therapy except emollients.

Also known as: UVA1
1

Eligibility Criteria

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

You may qualify if:

  • Patients with severe generalized atopic dermatitis (SCORAD Score \> 45)
  • Patients older than 18 years

You may not qualify if:

  • SCORAD Score \< 45
  • Pregnant and lactating women
  • Patients with severe general diseases
  • Abnormal UVA sensitivity
  • Intake of photosensitizing drugs
  • Local corticosteroid treatment \< 2 weeks before entering the study
  • Photo(chemo)therapy or systemic treatment for atopic dermatitis \< 4 weeks before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

5-MethoxypsoralenMethoxsalen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FurocoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Adrian Tanew, Prof. MD

    Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

AU(1)