Trial | NCT03632174  Report issue

Title

Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
Clinical Study for the Evaluation and Comparison of Cutaneous Acceptability and the Efficacy of 2 Cosmetic Products, Under Normal Conditions of Use, in Adult Participants With Atopic Dermatitis

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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 Started
Jan 21
2019
Primary Completion
Sep 02
2019
Study Completion
Oct 16
2019
Last Update
Oct 22
2019

Other Topical Ointment with L. reuteri

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

  • Other names: Probiotic ointment A

Other Topical Ointment without L. reuteri

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

  • Other names: Non Probiotic ointment B

Topical Ointment with L. reuteri Experimental

Adult subjects presenting with mild-moderate Atopic Dermatitis

Topical Ointment without L. reuteri Experimental

Adult subjects presenting with mild-moderate Atopic Dermatitis

Criteria 

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
No Results Posted