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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632174
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
BioGaia AB

Study Description
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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


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: Topical Ointment with L. reuteri Other: Topical Ointment without L. reuteri Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison of two cosmetic products
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Actual Study Start Date : January 21, 2019
Actual Primary Completion Date : September 2, 2019
Actual Study Completion Date : October 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Topical Ointment with L. reuteri
Adult subjects presenting with mild-moderate Atopic Dermatitis
 Other: Topical Ointment with L. reuteri
Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
Other Name: Probiotic ointment A
Experimental: Topical Ointment without L. reuteri
Adult subjects presenting with mild-moderate Atopic Dermatitis
 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 Name: Non Probiotic ointment B


Outcome Measures
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Primary Outcome Measures :
  1. Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator [ Time Frame: 4 weeks ]
    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)


Secondary Outcome Measures :
  1. Change in SCORAD index over 8 week period [ Time Frame: baseline, at 4 and 8 weeks ]
    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

  2. Change in Local SCORAD index [ Time Frame: baseline, at 4, and 8 weeks ]
    Change evaluated by the dermatologist investigator at each visit, on the recurrent lesion (defined area) and control area selected at baseline


Other Outcome Measures:
  1. Appraisal of cosmetic acceptability of the investigational products by participant questionnaire [ Time Frame: 4 weeks ]

    Cosmetic acceptability of the products through participant filling in questionnaire adapted to the products, elaborated in collaboration with the study monitor.

    The questionnaire will address functional and physical signs of a reaction (application frequency, nature, location, intensity, duration)

    Conclusion on cutaneous acceptability: Very good/ Good / Moderately Good / Bad



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632174


Locations
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South Africa
Unit 12B, Waverly Business Park
Cape Town, South Africa
Sponsors and Collaborators
BioGaia AB
Investigators
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Principal Investigator: Burgert Jaques Van Wyk, MB, ChB South African Medical Association
More Information
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Publications:

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Responsible Party: BioGaia AB
ClinicalTrials.gov Identifier: NCT03632174    
Other Study ID Numbers: CSUB0167
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioGaia AB:
Probiotic
Atopic Dermatitis
Lactobacillus reuteri
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases