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

B

BioGaia

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Other: Topical Ointment with L. reuteri
Other: Topical Ointment without L. reuteri

Study type

Interventional

Funder types

Industry

Identifiers

NCT03632174
CSUB0167

Details and patient eligibility

About

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

Full description

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.

Enrollment

36 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 2 patient groups

Topical Ointment with L. reuteri
Experimental group
Description:
Adult subjects presenting with mild-moderate Atopic Dermatitis
Treatment:
Other: Topical Ointment with L. reuteri
Topical Ointment without L. reuteri
Experimental group
Description:
Adult subjects presenting with mild-moderate Atopic Dermatitis
Treatment:
Other: Topical Ointment without L. reuteri

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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