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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00533195 |
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 |
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Atopic Dermatitis |
Drug: 5-Methoxypsoralen Device: UVA1 phototherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | UVA1 Phototherapy Versus 5-MOP UVA Photochemotherapy for Patients With Severe Generalized Atopic Dermatitis |
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 |
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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.
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Drug: 5-Methoxypsoralen
1,2 mg/kg 2 hours before UVA irradiation p.o. 3 times weekly for 5 weeks
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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.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology | |
Vienna, Austria, 1090 |
Principal Investigator: | Adrian Tanew, Prof. MD | Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology |
Responsible Party: | Medical University of Vienna ( Prof. Dr. Adrian Tanew ) |
Study ID Numbers: | 03/01/07, EudraCT-Nr.: 2006-00698217 |
Study First Received: | September 19, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00533195 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety; Austria: Ethikkommission |
UVA1 PUVA atopic dermatitis |
Photosensitizing Agents Hypersensitivity Dermatitis, Atopic Radiation-Sensitizing Agents Genetic Diseases, Inborn Skin Diseases |
Methoxsalen Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Emollients Dermatitis |
Dermatitis, Atopic Skin Diseases Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions Hypersensitivity Photosensitizing Agents Genetic Diseases, Inborn |
Radiation-Sensitizing Agents Methoxsalen Therapeutic Uses Hypersensitivity, Immediate Skin Diseases, Eczematous Dermatologic Agents Skin Diseases, Genetic Dermatitis |