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

This study has been completed.
Sponsor:
Information provided by:
L'Oreal
ClinicalTrials.gov Identifier:
NCT00509535
First received: July 30, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   6 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00509535     History of Changes
Other Study ID Numbers: 2005-AD-003
Study First Received: July 30, 2007
Last Updated: July 30, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 23, 2014