Comparison of UVA1 Phototherapy Versus Photochemotherapy for Patients With Severe Generalized Atopic Dermatitis
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: 5-Methoxypsoralen (Drug); UVA1 phototherapy (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s): Adrian Tanew, Prof. MD, Principal Investigator, Affiliation: Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology
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.
Clinical Details
Official title: UVA1 Phototherapy Versus 5-MOP UVA Photochemotherapy for Patients With Severe Generalized Atopic Dermatitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: remission duration after UVA1 phototherapy and after 5-MOP UVA photochemotherapy
Secondary outcome: 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
Detailed description:
The patients will be randomized assigned to UVA 1 phototherapy or to 5-MOP UVA
photochemotherapy as a first therapy. Besides emollients no additional treatment will be
allowed. First a detailed history inclusive drug history will be gathered. The skin type
will be determined and a clinical photo will be made. Prior to 5-MOP UVA photochemotherapy
an ophthalmological examination, blood cell count and blood chemistry will be routinely
performed. A determination of the serum level of 5 MOP will be routinely made at the minimal
phototoxic dose (MPD) determination before start of the 5-MOP UVA photochemotherapy. The
serum levels of total Ig E and eosinophilic cationic protein (ECP) will be additionally
determined at the start and at the end of each therapy. In all patients receiving 5-MOP UVA
photochemotherapy reliable eye protection by wearing photoprotective glasses during the
treatment and on the day of taking 5-MOP until night will take place. The skin of the
patients should not be exposed to direct sun light or to other artificial UV sources at the
day of irradiation. A determination of SCORAD Score will be performed by a blinded
investigator at baseline, after 10 and 15 irradiations as well as at every follow-up visit
at month 1, 3, 6 and 12. A clinical photo will be made at the beginning of each therapy, at
the end as well as at every follow-up visit. In case of a relapse (SCORAD Score > 50 % of
initial value), or on patients' request for a premature resumption of the therapy (despite
SCORAD Score > 50 %) patients will receive that treatment which have not been performed
until now. That means, patients who were treated with 5-MOP UVA as a first therapy will now
receive the UVA 1 phototherapy and vice versa. The minimum interval between the two
therapies is at least 1 month except in a case of complete non response on the first
therapy.
Irradiation protocol of the UVA 1 phototherapy:
Irradiation 5 x week for 3 weeks (altogether 15 exposures) Determination of the UVA 1 MED
prior to treatment Start with 1 MED if MED < 70 J/cm2. Increase of the dose by 20 % every
time if there is not an erythematous reaction and by good tolerability until a maximal dose
of 70 J/cm2.
Irradiation protocol of the 5-MOP UVA photochemotherapy:
Irradiation 3 x week for 5 weeks (altogether 15 exposures) Intake of 5-methoxypsoralen
(Geralen) 2 hours prior to each irradiation in a dose of 1. 2 mg/kg Determination of a
minimal phototoxic dose (MPD) prior to treatment Determination of the 5-MOP serum level at
the MPD testing Start with 70 % of MPD, no dose increments during the first week. From the
second week increase of the UVA dose by 20 % if there is no an erythematous response
(respectively by 10 % if there is a light erythemal reaction), but at the earliest 96 hours
after the last increment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with severe generalized atopic dermatitis (SCORAD Score > 45)
- Patients older than 18 years
Exclusion Criteria:
- 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
Locations and Contacts
Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology, Vienna 1090, Austria
Additional Information
Starting date: October 2007
Last updated: January 13, 2009
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