Atopic Dermatitis
Conditions
Keywords
Probiotic, Atopic Dermatitis, Lactobacillus reuteri
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.
Interventions
OTHERTopical Ointment with L. reuteri
Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
OTHERTopical Ointment without L. reuteri
Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
Sponsors
BioGaia AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Comparison of two cosmetic products
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Local SCORAD index | 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 |
| Change in SCORAD index over 8 week period | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Appraisal of cosmetic acceptability of the investigational products by participant questionnaire | 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 |
Countries
South Africa
Outcome results
None listed