Ignite Creation Date:
2024-05-05 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00549588
Status:
COMPLETED
Last Update Posted:
2009-09-30
First Post:
2007-10-24
Brief Title:
Sunscreen and After-sun-lotion Protection in Polymorphic Light Eruption
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
The Efficacy of a Sunscreen With SPF30 and a After-sun-lotion in the Prevention of Polymorphic Light Eruption
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polymorphic light eruption PLE is a common photodermatosis characterized by the appearance of itching erythema papules or vesicles on sun-exposed skin Though etiology is unclear it is hypothesized that it is an abnormal immune response to autologous antigens generated by ultraviolet radiation UVR This randomized double blinded left-right body side experimental comparison study was designed to assess the preventive effect of a sunscreen and topical DNA repair enzyme-containing after-sun lotion in PLE
Detailed Description:
A SPF 30 sunscreen containing chemical and physical UV filters an after-sun lotion containing liposomal encapsulated micrococcus luteus lysate with endonuclease activity and photolyase active AS and an after-sun placebo formulation containing no DNA repair enzymes placebo AS has been used in this study Fourteen PLE patients were enrolled On day 1 the individual minimal erythema dose MED was assessed on patients buttock skin by exposure to a test ladder of solar-simulated UVR xenon arc source Oriel Corp Darmstadt Germany From day 2 to 5 075 individual MED exposures increased by 0 to 25 per exposure depending on the erythema response to a preceding dose were given to a total of four 5-by-5 cm skin test fields on symmetrically located individual PLE predilection sites on the trunk or extremities The test fields were treated in randomized and double-blinded fashion either with SPF30 sunscreen 20 min before UVR exposure active AS or placebo AS all creams at a concentration of 2mgcm2 immediately after UVR exposure or left untreated Sixty minutes after UVR exposure all test areas were treated with visible light 400 to 450nm 5Jcm2 to activate the light dependent photolyase DNA repair mechanism The photo test procedure led to the appearance of PLE symptoms in unprotected test fields of 1214 86 patients active AS-treated test fields of 614 43 patients p005 placebo AS-treated test fields of 1014 71 patients p ns and no 0 sunscreen-protected test fields of any patient p00001 vs unprotected test fields Fisher exact test These results provide evidence that i DNA damage is a trigger of PLE ii increasing DNA repair can prevent induction of PLE symptoms and iii the use of sun care preparations containing DNA repair enzymes may be clinically useful for PLE patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None