Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2001-05-31
2002-02-28
Brief Summary
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Previous studies have demonstrated that the lesions in LE patients reproduced in controlled experimental conditions. The initial reports suggested that the action spectrum for the LE was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320 to 400 nm) can contribute to the induction of LE skin lesions.
Antimalarial agents and topical steroids are the main treatments of chronic LE. The second line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing and to apply sunscreen.
The aim of this study was to assess the efficacy of a sunscreen milk with high protection factor against UV-B and UV-A, used exclusively, in the photoinduced LE.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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sunscreen RV 2547C
Eligibility Criteria
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Inclusion Criteria
* Patient aged of 18 years or more
* Documented medical history of chronic cutaneous lupus erythematosus (lupus erythematosus tumidus, discoid lupus erythematosus, subacute lupus erythematosus) without any sign of systematic involvement
* patients who have a history of positive provocative phototestimg using a standardized protocol during a previous photobiologic exploration
* informed consent
Exclusion Criteria
* subjects with lupus erythematosus with systematic involvement
* subjects with a medical history of another photodermatosis
* subjects with sun erythema, residual pigmentation, dermatological lesion, abnormal skin pigmentation which might interfere with a study evaluation on test sides
* subjects who had sun solar simulator exposure on their backs within 12 weeks prior to enter to the study
* subjects with a known intolarance to one of the formula compounds
18 Years
70 Years
ALL
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Principal Investigators
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Annegret Kuhn, MD
Role: PRINCIPAL_INVESTIGATOR
Heinrich-Heine University of Duesseldorf, Department of Dermatolgy
Locations
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Heinrich Heine University of Duesseldorf, Depatment of Dermatoly
Düsseldorf, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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AMG 003
Identifier Type: -
Identifier Source: org_study_id