Prospective, Randomized, Double Blind Comparative Study on the Use of Two Creams in Xerosis Atopic Probands
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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 |
- 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). ]
- • 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 |
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 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 Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013