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

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Device: UVA1 phototherapy; Drug: 5-Methoxypsoralen

• Registration Number: NCT00533195
• Lead Sponsor: Medical University of Vienna

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.

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.

Study Timeline

• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-21
• Study Start: 2007-10
• Status Verified: 2009-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-01-13
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	UVA1 phototherapy	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.
0	5-Methoxypsoralen	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.

Primary Outcome Measures

Name	Time	Method
remission duration after UVA1 phototherapy and after 5-MOP UVA photochemotherapy	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology; 🇦🇹 Vienna, Austria