Clinical Trial: Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Investigation of the Efficacy of Different Sunscreens in Patients With Photosensitive Cutaneous Lupus Erythematosus
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 Summary:
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.
Sponsor: Spirig Pharma Ltd.
Current Primary Outcome: Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE [ Time Frame: September 2011 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Spirig Pharma Ltd.
Dates:
Date Received: May 24, 2010
Date Started: November 2009
Date Completion:
Last Updated: March 8, 2016
Last Verified: December 2013