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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00470912
Other study ID # AMG 003
Secondary ID
Status Completed
Phase Phase 3
First received May 7, 2007
Last updated May 7, 2007
Start date May 2001
Est. completion date February 2002

Study information

Verified date May 2007
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
sunscreen RV 2547C


Locations

Country Name City State
Germany Heinrich Heine University of Duesseldorf, Depatment of Dermatoly Duesseldorf NRW

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

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