Cutaneous Lupus Erythematosus
Conditions
Keywords
Sunscreening Agents
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.
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.
Interventions
OTHERUV A and B irradiation
UV irradiation
Sponsors
Spirig Pharma Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE | September 2011 |
Countries
Germany
Outcome results
None listed