comparison of uva1 phototherapy versus photochemotherapy for patients with severe generalized atopic dermatitis

Conditions: Atopic Dermatitis

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.

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 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

Keywords: uva1 puva atopic dermatitis