Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
NCT ID: NCT03632174
Last Updated: 2019-10-22
Study Results
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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COMPLETED
NA
36 participants
INTERVENTIONAL
2019-01-21
2019-10-16
Brief Summary
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It is carried out on cosmetic products, with the aim to further confirm safety of these products
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Topical Ointment with L. reuteri
Adult subjects presenting with mild-moderate Atopic Dermatitis
Topical Ointment with L. reuteri
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
Topical Ointment without L. reuteri
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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BioGaia AB
INDUSTRY
Responsible Party
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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
Countries
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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.
Other Identifiers
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CSUB0167
Identifier Type: -
Identifier Source: org_study_id
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