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

NCT00509535 | Completed DMC

• 1 other identifier: 2005-AD-003
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Vitreoscilla filiformis extract; SCORAD; pruritus; microflora; TEWL

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation SCORAD. In addition a visual analogue scale for subjective estimation of pruritus

  at day 0 (visit 1), at day 15 (visit 2) and at least at day 29 (visit 3).

Secondary Outcomes (1)

• • Evaluation of TEWL • Qualitative and quantitative analyses of skin microflora • Proband's questionnaire about oiliness, distribution, consistency and adsorption of the creams

  day 0 (visit 1), at day 15 (visit 2) and at least at day 29 (visit 3).

Interventions

vitreoscilla filiformis cream DRUG

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

Eberhard karls University-Dept Dermatology

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tilo Biedermann, Pr PhD, MD

  Eberhard Karls University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: July 31, 2007
• Study Start: January 1, 2005
• Study Completion: June 1, 2007
• Last Updated: July 31, 2007

Record last verified: 2007-07

Locations

DE (1)