Sunscreen RV 2457C in Photoinduced CLE - Tabular View

Tracking Information

First Received Date ^ICMJE

May 7, 2007

Last Updated Date

May 7, 2007

Start Date ^ICMJE

May 2001

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Sunscreen RV 2457C in Photoinduced CLE

Official Title ^ICMJE

Photoprotective Effects of the RV 2457C Sunscreen Milk in Photoinduced Cutaneous Lupus Erythematosus

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 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Cutaneous Lupus Erythematosus
Skin Lesion
Experimental Photoinduction
Protective Sunscreen

Intervention ^ICMJE

Drug: sunscreen RV 2547C

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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 Criteria:

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Expanded Access Status

Administrative Information

NCT ID ^ICMJE

NCT00470912

Responsible Party

Study ID Numbers ^ICMJE

AMG 003

Study Sponsor ^ICMJE

Heinrich-Heine University, Duesseldorf

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Annegret Kuhn, MD

Heinrich-Heine University of Duesseldorf, Department of Dermatolgy

Information Provided By

Heinrich-Heine University, Duesseldorf

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP