Cutaneous Lupus Erythematosus Clinical Trial
Official title:
Investigation of the Efficacy of Different Sunscreens in Patients With Photosensitive Cutaneous Lupus Erythematosus
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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