Comparison of UVA1 Phototherapy Versus Photochemotherapy for Patients With Severe Generalized Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00533195
First received: September 19, 2007
Last updated: January 13, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: 5-Methoxypsoralen
Device: UVA1 phototherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: UVA1 Phototherapy Versus 5-MOP UVA Photochemotherapy for Patients With Severe Generalized Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • remission duration after UVA1 phototherapy and after 5-MOP UVA photochemotherapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0
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
1,2 mg/kg 2 hours before UVA irradiation p.o. 3 times weekly for 5 weeks
Other Name: 5-MOP, Geralen
Experimental: 1
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

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.

Other Name: UVA1

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00533195

Locations
Austria
Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Adrian Tanew, Prof. MD Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology
  More Information

No publications provided

Responsible Party: Prof. Dr. Adrian Tanew, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00533195     History of Changes
Other Study ID Numbers: 03/01/07, EudraCT-Nr.: 2006-00698217
Study First Received: September 19, 2007
Last Updated: January 13, 2009
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
UVA1
PUVA
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methoxsalen
5-methoxypsoralen
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 31, 2014