Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis

BioGaia AB36 enrolled

Overview

The study consists in the application of 2 investigational products (one group per investigational product) under normal conditions of use, in adult participants with Atopic Dermatitis. It is carried out on cosmetic products, with the aim to further confirm safety of these products

Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects of Lactobacillus reuteri have been extensively studied in the gastrointestinal tract but it is clear that other areas are also interesting for the use of probiotics. Atopic Dermatitis is a relapsing inflammatory skin disease appearing on persons with a genetic predisposition of allergic pathology. AD generally starts in childhood, however in some cases can continue into adult hood, in at least 10% of cases. AD can effect a persons quality of life and in the chronic stage it can present with dry skin and lichenification. Research has shown that probiotics have an antimicrobial, anti-inflammatory and barrier function effect, and could therefore be used on subjects with Atopic Dermatitis to relieve and protect.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Topical Ointment with L. reuteriOTHER

Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body

Topical Ointment without L. reuteriOTHER

Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant has not been on a course of long term treatment in particular with aspirin, products containing aspirin, anti-inflammatories, antibiotics, antihistamines, corticoids * Participant presenting with mild to moderate atopic dermatitis according to the definition of the UK Working Party's Diagnostic Criteria for Atopic Dermatitis (SCORAD index \>25) * Participant presenting with a current lesion of Atopic Dermatitis on defined area Exclusion Criteria: * Participant is pregnant, breast feeding or not willing to take the necessary precautions to avoid pregnancy during the study * Participant having background of intolerance or allergy * Participant not respecting the washout period during which a person may not be involved in any other biomedical research projects * Participant having skin exposed to sunlight within 2 weeks preceding the inclusion * Participant having modified his/her cosmetic habits during the last two weeks

Locations (1)

Unit 12B, Waverly Business Park

Cape Town, South Africa

Outcomes

Primary Outcomes

Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator

Cutaneous acceptability is assessed on the basis of clinical examination of the skin for physical signs (erythema, oedema, dryness) linked to the use of the investigational product and also evaluation the functional signs (prickling, tightness, heating)

Time frame: 4 weeks

Secondary Outcomes

Change in SCORAD index over 8 week period

Clinical evaluation by the dermatologist investigator to assess change in skin conditions to each parameter of "SCORing Atopic Dermatitis" (SCORAD) (erythema, edema, xerosis) and participant symptoms: pruritus and sleep quality

Time frame: baseline, at 4 and 8 weeks

Change in Local SCORAD index

Change evaluated by the dermatologist investigator at each visit, on the recurrent lesion (defined area) and control area selected at baseline

Time frame: baseline, at 4, and 8 weeks

Data from ClinicalTrials.gov

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