Back to results

Sunscreen RV 2457C in Photoinduced CLE

Primary Purpose

Cutaneous Lupus Erythematosus, Skin Lesion, Experimental Photoinduction

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

sunscreen RV 2547C

About this trial

This is an interventional prevention trial for Cutaneous Lupus Erythematosus focused on measuring cutaneous lupus erythemaosus, photoprotection, photoprovocation, Sunscreen RV 2547C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Heinrich Heine University of Duesseldorf, Depatment of Dermatoly

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00470912

First Posted

May 7, 2007

Last Updated

May 7, 2007

Sponsor

Heinrich-Heine University, Duesseldorf

1. Study Identification

Unique Protocol Identification Number

NCT00470912

Brief Title

Sunscreen RV 2457C in Photoinduced CLE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

May 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Heinrich-Heine University, Duesseldorf

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

sunscreen RV 2547C

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annegret Kuhn, MD

Organizational Affiliation

Heinrich-Heine University of Duesseldorf, Department of Dermatolgy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Heinrich Heine University of Duesseldorf, Depatment of Dermatoly

City

Duesseldorf

State/Province

NRW

ZIP/Postal Code

40225

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Sunscreen RV 2457C in Photoinduced CLE

We'll reach out to this number within 24 hrs