sunscreens in patients with cutaneous lupus erythematosus(cle)

Conditions: Cutaneous Lupus Erythematosus

Summary: part i: to investigate the efficacy of different sunscreens in the prevention of skin lesions following standardized photoprovocation with ultraviolet a/ultraviolet b (uva/uvb) light in patients with cle. part ii: to evaluate the influence of different sunscreens on the expression of biomarkers in the skin of patients with cle and of healthy controls following uv irradiation.

part i part i-interventions will be: * experimental intervention: application of broad-spectrum sunscreens with a low, medium, and high sun protection factor (spf) in random order to uninvolved skin areas prior to standardized photoprovocation. * control intervention: intra-individual application of vehicle in random order; standardized photoprovocation of vehicle treated and untreated areas. part ii part ii-interventions will be: * experimental intervention: application of a broad-spectrum sunscreen with a high spf to uninvolved skin areas prior to uv irradiation. * control intervention: uv irradiation of untreated areas.

Eligibility criteria:
inclusion criteria: * patients with subacute cutaneous lupus erythematosus (scle), discoid lupus erythematosus (dle), or lupus erythematosus tumidus (let) according to the düsseldorf classification 2004 (kuhn and ruzicka 2004) confirmed by histological analysis. * women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, \>3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last uv exposure. * women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation). * actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times. * development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of cle. * signed informed consent form after the nature of the study has been fully explained. exclusion criteria: * pregnancy or lactation and women with positive pregnancy test. * known hypersensitivity or allergic contact reactions to components of the study agents. * treatment with photosensitizing drugs. * exposure to direct natural (sunlight) or artificial uv radiation on the back within 4 weeks prior to entering the study. * history of another photodermatosis, except polymorph light eruption (ple). * any current known skin malignancy or any history of skin malignancy within the previous 5 years or xeroderma pigmentosum. * initiation or change in the dose of any current systemic medication for the treatment of cle within 8 weeks prior to standardized photoprovocation. * local therapy for the treatment of cle within two weeks prior to standardized photoprovocation at the back of the patient * acute exacerbation of cle skin disease within 2 weeks prior to entering the study. * acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry. * anti-dsdna (ria) \> 7 u/ml and/or at least one of the following criteria: * serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion; * renal disorder: proteinuria greater than 0.5 g/d or greater than 3+, or cellular casts; * neurologic disorder: seizures or psychosis without other cause. * patients with a documented hiv and/or hepatitis b or c infection. * any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained

Keywords: sunscreening agents