Status:
COMPLETED
Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)
Lead Sponsor:
Spirig Pharma Ltd.
Conditions:
Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01146444
Start Date
November 1 2009
End Date
November 1 2012
Last Update
March 9 2016
Active Locations (1)
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1
Klinik und Poliklinik für Hautkrankheiten, Universitätsklinikum Münster
Münster, Germany, 48149