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Sponsored by: |
L'Oreal |
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Information provided by: | L'Oreal |
ClinicalTrials.gov Identifier: | NCT00509535 |
Atopic dermatitis (AD), a chronic and relapsing inflammatory skin disease, is associated with elevated IgE levels and Th2 responses. It is currently believed that non-pathogenic bacteria modulate intestinal immune responses avoiding the development of allergic diseases. However, effects of oral probiotics on AD could not be reproduced in all studies and direct immuno-modulation of the skin associated immune response by non-pathogenic bacteria has not been investigated so far. We therefore performed a double blind placebo controlled clinical study on the effects of an ointment containing 5% extracts of the non-pathogenic bacteria Vitreoscilla filiformis on AD. Seventy-five AD patients (6-70 years of age) were randomized to receive either Vitreoscilla filiformis ointment 5% or vehicle ointment daily for 30 days. Efficacy evaluations, including the "Score of Atopic Dermatitis" (SCORAD), transepidermal water loss, assessement of microflora, and the patient assessment of itch and loss of sleep occurred at baseline, day 15, and day 29.
Condition | Intervention |
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Atopic Dermatitis |
Drug: vitreoscilla filiformis cream |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Randomized, Double Blind Comparative Study on the Use of Two Creams in Xerosis Atopic Probands Biomedical Findings With Vitreoscilla Filiformis |
Enrollment: | 75 |
Study Start Date: | January 2005 |
Study Completion Date: | June 2007 |
Ages Eligible for Study: | 6 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Retraction of the written informed consent
Study ID Numbers: | 2005-AD-003 |
Study First Received: | July 30, 2007 |
Last Updated: | July 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00509535 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Vitreoscilla filiformis extract SCORAD pruritus microflora TEWL |
Pruritus Signs and Symptoms Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn |
Skin Diseases Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Immune System Diseases |