Status:
COMPLETED
Sunscreen RV 2457C in Photoinduced CLE
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Cutaneous Lupus Erythematosus
Skin Lesion
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- Male or female subjects
- 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
- Pregnant women, nursing mothers
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2002
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00470912
Start Date
May 1 2001
End Date
February 1 2002
Last Update
May 8 2007
Active Locations (1)
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1
Heinrich Heine University of Duesseldorf, Depatment of Dermatoly
Düsseldorf, North Rhine-Westphalia, Germany, 40225