Sunscreen RV 2457C in Photoinduced CLE

Heinrich-Heine University, Duesseldorf

Status and phase

Completed

Phase 3

Conditions

Cutaneous Lupus Erythematosus

Protective Sunscreen

Skin Lesion

Experimental Photoinduction

Treatments

Drug: sunscreen RV 2547C

Study type

Interventional

Funder types

Other

Identifiers

NCT00470912

AMG 003

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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