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Sunscreen RV 2457C in Photoinduced CLE

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470912
First Posted: May 8, 2007
Last Update Posted: May 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heinrich-Heine University, Duesseldorf
  Purpose

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.


Condition Intervention Phase
Cutaneous Lupus Erythematosus Skin Lesion Experimental Photoinduction Protective Sunscreen Drug: sunscreen RV 2547C Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Photoprotective Effects of the RV 2457C Sunscreen Milk in Photoinduced Cutaneous Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Enrollment: 25
Study Start Date: May 2001
Study Completion Date: February 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470912


Locations
Germany
Heinrich Heine University of Duesseldorf, Depatment of Dermatoly
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Annegret Kuhn, MD Heinrich-Heine University of Duesseldorf, Department of Dermatolgy
  More Information

ClinicalTrials.gov Identifier: NCT00470912     History of Changes
Other Study ID Numbers: AMG 003
First Submitted: May 7, 2007
First Posted: May 8, 2007
Last Update Posted: May 8, 2007
Last Verified: May 2007

Keywords provided by Heinrich-Heine University, Duesseldorf:
cutaneous lupus erythemaosus
photoprotection
photoprovocation
Sunscreen RV 2547C

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents