Clinical trial NCT03632174: Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Probiotic
Atopic Dermatitis
Lactobacillus reuteri
Lead sponsor: BioGaia AB
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of two cosmetic products
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in SCORAD index over 8 week period
timeFrame: baseline, at 4 and 8 weeks
measure: Change in Local SCORAD index
timeFrame: baseline, at 4, and 8 weeks
Other outcomes:
measure: Appraisal of cosmetic acceptability of the investigational products by participant questionnaire
timeFrame: 4 weeks
Locations:
city: Cape Town
country: South Africa
facility: Unit 12B, Waverly Business Park
Study officials:
affiliation: South African Medical Association
name: Burgert Jaques Van Wyk, MB, ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. J Allergy Clin Immunol. 2003 Feb;111(2):389-95. doi: 10.1067/mai.2003.389.