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

NCT ID: NCT03632174

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2019-10-16

Brief Summary

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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

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of two cosmetic products
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Topical Ointment with L. reuteri

Adult subjects presenting with mild-moderate Atopic Dermatitis

Group Type EXPERIMENTAL

Topical Ointment with L. reuteri

Intervention Type OTHER

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

Topical Ointment without L. reuteri

Adult subjects presenting with mild-moderate Atopic Dermatitis

Group Type EXPERIMENTAL

Topical Ointment without L. reuteri

Intervention Type OTHER

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

Interventions

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Topical Ointment with L. reuteri

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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Probiotic ointment A Non Probiotic ointment B

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioGaia AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Burgert Jaques Van Wyk, MB, ChB

Role: PRINCIPAL_INVESTIGATOR

South African Medical Association

Locations

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Unit 12B, Waverly Business Park

Cape Town, , South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type BACKGROUND
PMID: 12589361 (View on PubMed)

Other Identifiers

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CSUB0167

Identifier Type: -

Identifier Source: org_study_id

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