An interventional study of After-sun-lotion with DNA repair enzymes and SPF30 sunscreen in Polymorphic Light Eruption, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2009-09-30.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Prevention
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.
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.
79 studies on the registry are indexed under Exanthema; 12 are open to participants now.
This study's enrollment of 14 is below the median of 42 across 58 interventional studies indexed under Exanthema.
Browse Exanthema studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 101 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 mg/cm2 immediately after UV exposure
Also known as: Proprietary after-sun lotion (Ateia Inc.)
2 mg/cm2 2o min before UV exposure
Also known as: SPF30 sunscreen (Ateia Inc.)
2mg/cm2 immediately after UV exposure
Also known as: Proprietary after sun lotion vehicle (Ateia Inc.)
Occurrence of symptoms of polymorphic light eruption
Time frame: Prospective
Pruritus
Time frame: Prospective
Skin infiltration
Time frame: prospective
Area affected
Time frame: prospective
Erythema
Time frame: prospective
Tanning
Time frame: Prospective
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Graz