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

Study Overview
=================
Brief Summary
-----------------
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

Detailed 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.

Official Title
-----------------
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

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: Topical Ointment with L. reuteri
* Other: Topical Ointment without L. reuteri


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of two cosmetic products
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Ointment with L. reuteri<br>Adult subjects presenting with mild-moderate Atopic Dermatitis | Other: Topical Ointment with L. reuteri<br>* Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body<br>* Other names: Probiotic ointment A;|
| Experimental: Topical Ointment without L. reuteri<br>Adult subjects presenting with mild-moderate Atopic Dermatitis | Other: Topical Ointment without L. reuteri<br>* Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body<br>* Other names: Non Probiotic ointment B;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | baseline, at 4, and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotic, Atopic Dermatitis, Lactobacillus reuteri