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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: L'Oreal

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• patients where conventional antiinflammatory therapy cannot be withdrawn are excluded