Trial record 3 of 113 for:    MOPS

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
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
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014