Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE) (NCT01146444) | Clinical Trial Compass
CompletedNot Applicable
Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)
Germany20 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 t…
What they're measuring
1
Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE