Sunscreen RV 2457C in Photoinduced CLE - Full Text View

Sponsored by:	Heinrich-Heine University, Duesseldorf
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00470912

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Photoprotective Effects of the RV 2457C Sunscreen Milk in Photoinduced Cutaneous Lupus Erythematosus

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470912

Locations

Germany, NRW
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

Study ID Numbers:	AMG 003
Study First Received:	May 7, 2007
Last Updated:	May 7, 2007
ClinicalTrials.gov Identifier:	NCT00470912 History of Changes
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

Study placed in the following topic categories:

Radiation-Protective Agents
Cutaneous Lupus Erythematosus
Autoimmune Diseases
Skin Diseases
Lupus Erythematosus, Systemic

Lupus
Lupus Erythematosus, Cutaneous
Sunscreening Agents
Connective Tissue Diseases

Additional relevant MeSH terms:

Radiation-Protective Agents
Autoimmune Diseases
Skin Diseases
Immune System Diseases
Lupus Erythematosus, Cutaneous
Physiological Effects of Drugs
Protective Agents

Pharmacologic Actions
Lupus Erythematosus, Systemic
Therapeutic Uses
Connective Tissue Diseases
Sunscreening Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009