Back to resultsEvaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Topical Ointment with L. reuteri
Topical Ointment without L. reuteri
Sponsored by
About this trial
This is an interventional other trial for Atopic Dermatitis focused on measuring Probiotic, Atopic Dermatitis, Lactobacillus reuteri
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
Sites / Locations
- Unit 12B, Waverly Business Park
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Topical Ointment with L. reuteri
Topical Ointment without L. reuteri
Arm Description
Adult subjects presenting with mild-moderate Atopic Dermatitis
Adult subjects presenting with mild-moderate Atopic Dermatitis
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03632174
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGaia AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Probiotic, Atopic Dermatitis, Lactobacillus reuteri
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of two cosmetic products
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Ointment with L. reuteri
Arm Type
Experimental
Arm Description
Adult subjects presenting with mild-moderate Atopic Dermatitis
Arm Title
Topical Ointment without L. reuteri
Arm Type
Experimental
Arm Description
Adult subjects presenting with mild-moderate Atopic Dermatitis
Intervention Type
Other
Intervention Name(s)
Topical Ointment with L. reuteri
Other Intervention Name(s)
Probiotic ointment A
Intervention Description
Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
Intervention Type
Other
Intervention Name(s)
Topical Ointment without L. reuteri
Other Intervention Name(s)
Non Probiotic ointment B
Intervention Description
Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
Primary Outcome Measure Information:
Title
Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator
Description
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in SCORAD index over 8 week period
Description
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
Time Frame
baseline, at 4 and 8 weeks
Title
Change in Local SCORAD index
Description
Change evaluated by the dermatologist investigator at each visit, on the recurrent lesion (defined area) and control area selected at baseline
Time Frame
baseline, at 4, and 8 weeks
Other Pre-specified Outcome Measures:
Title
Appraisal of cosmetic acceptability of the investigational products by participant questionnaire
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burgert Jaques Van Wyk, MB, ChB
Organizational Affiliation
South African Medical Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit 12B, Waverly Business Park
City
Cape Town
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12589361
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.
Results Reference
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Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
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