Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT03632174 |
Recruitment Status :
Completed
First Posted : August 15, 2018
Last Update Posted : October 22, 2019
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Other: Topical Ointment with L. reuteri Other: Topical Ointment without L. reuteri | Not Applicable |
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 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 |

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
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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 |
- 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)
- 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
- 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
- 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

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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 |
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

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
South Africa | |
Unit 12B, Waverly Business Park | |
Cape Town, South Africa |
Principal Investigator: | Burgert Jaques Van Wyk, MB, ChB | South African Medical Association |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Probiotic Atopic Dermatitis Lactobacillus reuteri |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |