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Sponsored by: |
Medical University of Graz |
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Information provided by: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT00549588 |
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.
Condition | Intervention |
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Polymorphic Light Eruption |
Other: After-sun-lotion with DNA repair enzymes Other: SPF30 sunscreen Other: Placebo after-sun-lotion Other: Intervention: none (only UV) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Efficacy of a Sunscreen With SPF30 and a After-Sun-Lotion in the Prevention of Polymorphic Light Eruption |
Enrollment: | 14 |
Study Start Date: | February 2004 |
Study Completion Date: | August 2006 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
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, 0.75 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 2mg/cm2) immediately after UVR exposure, or left untreated. Sixty minutes after UVR exposure all test areas were treated with visible light (400 to 450nm, 5J/cm2) 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 12/14 (86%) patients, active AS-treated test fields of 6/14 (43%) patients (p<0.05), placebo AS-treated test fields of 10/14 (71%) patients (p, ns), and no (0%) sunscreen-protected test fields of any patient (p<0.0001 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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Medical University of Graz, Department of Dermatology | |
Graz, Austria, A-8036 |
Principal Investigator: | Peter Wolf, MD | Medical University of Graz |
Responsible Party: | Medical University of Graz, Austria ( Peter Wolf, MD, Principal Investigator ) |
Study ID Numbers: | 14-058 ex 03/04 |
Study First Received: | October 24, 2007 |
Last Updated: | July 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00549588 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women |
Polymorphic light eruption UV radiation photoprotection |
sunscreen DNA repair enzymes after-sun-lotion |
Exanthema Radiation-Protective Agents Skin Diseases Sunscreening Agents |
Skin Diseases, Eczematous Dermatitis, Contact Dermatitis |
Exanthema Radiation-Protective Agents Skin Diseases Therapeutic Uses Physiological Effects of Drugs Sunscreening Agents |
Skin Diseases, Eczematous Dermatologic Agents Protective Agents Dermatitis, Contact Pharmacologic Actions Dermatitis |