Sunscreen RV 2457C in Photoinduced CLE

Skin Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470912
• Other study ID #: AMG 003
• 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
• 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

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Experimental Photoinduction
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic
• Protective Sunscreen
• Skin Lesion

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,