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Sunscreen RV 2457C in Photoinduced CLE

This study has been completed.
Sponsor:
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00470912
First received: May 7, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00470912     History of Changes
Other Study ID Numbers: AMG 003
Study First Received: May 7, 2007
Last Updated: May 7, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 27, 2014