Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: sunscreens with a low, medium, high SPF sunscreens with a low, medium, and high SPF. UVA and UVB irradiation |
Other: UV A and B irradiation
UV irradiation
|
| Experimental: vehicle Intra-individual application of vehicle in random order; UVA and UVB irradiation |
Other: UV A and B irradiation
UV irradiation
|
Outcome Measures
Primary Outcome Measures
- Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE [September 2011]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinik und Poliklinik für Hautkrankheiten, Universitätsklinikum Münster | Münster | Germany | 48149 |
Sponsors and Collaborators
- Spirig Pharma Ltd.
Investigators
- Principal Investigator: Annegret Kuhn, MD, Professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DL0814-SPRG0801/KHMR