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Sponsored by: |
Heinrich-Heine University, Duesseldorf |
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Information provided by: | Heinrich-Heine University, Duesseldorf |
ClinicalTrials.gov Identifier: | NCT00470912 |
Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well established factor in the induction and exacerbation of this disease. In all subsets of LE, skin lesions occur preferentially in sun-exposed areas.
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.
Condition | Intervention | Phase |
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Cutaneous Lupus Erythematosus Skin Lesion Experimental Photoinduction Protective Sunscreen |
Drug: sunscreen RV 2547C |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Photoprotective Effects of the RV 2457C Sunscreen Milk in Photoinduced Cutaneous Lupus Erythematosus |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, NRW | |
Heinrich Heine University of Duesseldorf, Depatment of Dermatoly | |
Duesseldorf, NRW, Germany, 40225 |
Principal Investigator: | Annegret Kuhn, MD | Heinrich-Heine University of Duesseldorf, Department of Dermatolgy |
Study ID Numbers: | AMG 003 |
Study First Received: | May 7, 2007 |
Last Updated: | May 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00470912 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
cutaneous lupus erythemaosus photoprotection photoprovocation Sunscreen RV 2547C |
Radiation-Protective Agents Cutaneous Lupus Erythematosus Autoimmune Diseases Skin Diseases Lupus Erythematosus, Systemic |
Lupus Lupus Erythematosus, Cutaneous Sunscreening Agents Connective Tissue Diseases |
Radiation-Protective Agents Autoimmune Diseases Skin Diseases Immune System Diseases Lupus Erythematosus, Cutaneous Physiological Effects of Drugs Protective Agents |
Pharmacologic Actions Lupus Erythematosus, Systemic Therapeutic Uses Connective Tissue Diseases Sunscreening Agents Dermatologic Agents |