Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Investigation of the Efficacy of Different Sunscreens in Patients With Photosensitive Cutaneous Lupus Erythematosus|
- Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE [ Time Frame: September 2011 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||November 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Other: Daylong products
topical: 2 mg/cm2
Other Name: Sunscreens with low, medium and high SFP
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-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146444
|Klinik und Poliklinik für Hautkrankheiten, Universitätsklinikum Münster|
|Münster, Germany, 48149|
|Principal Investigator:||Annegret Kuhn, MD||Professor|