Sunscreen RV 2457C in Photoinduced CLE

NCT00470912 | Completed Phase 3

• 1 other identifier: AMG 003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Lupus Erythematosus; Skin Lesion; Experimental Photoinduction; Protective Sunscreen

Keywords

cutaneous lupus erythemaosus; photoprotection; photoprovocation; Sunscreen RV 2547C

Interventions

sunscreen RV 2547C DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Heinrich Heine University of Duesseldorf, Depatment of Dermatoly

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Annegret Kuhn, MD

  Heinrich-Heine University of Duesseldorf, Department of Dermatolgy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 8, 2007
• Study Start: May 1, 2001
• Study Completion: February 1, 2002
• Last Updated: May 8, 2007

Record last verified: 2007-05

Locations

DE (1)