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Prospective, Randomized, Double Blind Comparative Study on the Use of Two Creams in Xerosis Atopic Probands

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509535
First Posted: July 31, 2007
Last Update Posted: July 31, 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:
L'Oreal
  Purpose
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
Atopic Dermatitis Drug: vitreoscilla filiformis cream

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double Blind Comparative Study on the Use of Two Creams in Xerosis Atopic Probands Biomedical Findings With Vitreoscilla Filiformis

Resource links provided by NLM:


Further study details as provided by L'Oreal:

Primary Outcome Measures:
  • Clinical evaluation SCORAD. In addition a visual analogue scale for subjective estimation of pruritus [ Time Frame: at day 0 (visit 1), at day 15 (visit 2) and at least at day 29 (visit 3). ]

Secondary Outcome Measures:
  • • Evaluation of TEWL • Qualitative and quantitative analyses of skin microflora • Proband`s questionnaire about oiliness, distribution, consistency and adsorption of the creams [ Time Frame: day 0 (visit 1), at day 15 (visit 2) and at least at day 29 (visit 3). ]

Enrollment: 75
Study Start Date: January 2005
Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with mild atopic dermatitis are included.
  • The eczematous lesions may not pass over 5% of the total body surface.
  • The lesions may not weep.

Exclusion Criteria:

  • Past history of severe scaring by skin surgery
  • Past history of cutaneous cancer, malignant melanoma
  • Patient who show a lack of compliance
  • Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
  • Allergy or incompatibility of one of the components of the cream
  • Pregnant or breast feading woman
  • Retraction of the written informed consent

    • Patients who cannot keep untreated with topical steroids are not included. Patients with severe or infected atopic dermatitis are excluded
    • patients where conventional antiinflammatory therapy cannot be withdrawn are excluded
  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): NCT00509535


Locations
Germany
Eberhard karls University-Dept Dermatology
Tubingen, Germany, 72076
Sponsors and Collaborators
L'Oreal
Investigators
Principal Investigator: Tilo Biedermann, Pr PhD, MD Eberhard Karls University
  More Information

ClinicalTrials.gov Identifier: NCT00509535     History of Changes
Other Study ID Numbers: 2005-AD-003
First Submitted: July 30, 2007
First Posted: July 31, 2007
Last Update Posted: July 31, 2007
Last Verified: July 2007

Keywords provided by L'Oreal:
Vitreoscilla filiformis extract
SCORAD
pruritus
microflora
TEWL

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases