Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Probiotic, Microbiome, Ointment
Brief summary
This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
Interventions
OTHERProbiotic Ointment
Probiotic ointment
OTHERComparator product
Basic lotion
Sponsors
BioGaia AB
Zurko Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 15 Years
Healthy volunteers
No
Inclusion criteria
Male and female pediatric patients aged 0.5 years to 15 years with Atopic Dermatitis. SCORAD Index at D0 = 15 to 50, inclusive. In goodgeneral health as reported by the parent(s)/legal representative(s). Available for the full duration of the study and willing to comply with procedures. Subjects whose parents or legal representative are willing to sign the informed consent.
Exclusion criteria
Use of phototherapy for atopic dermatitis. Use of systemic corticosteroids within 2 weeks prior to the study. Use of Immunosuppressive or cytostatic drugs within 1 months prior to the study. Use of antibiotics (topical and systemic) within 15 days prior to the start of the study. Subjects who are treated with vitamin A-derived compounds or other topical medications for acne in the experimental area during the 30 days prior to the start of the study. History of sensitivity to the study products, or its components. History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis). Subjects with active infection in atopic dermatitis areas requiring antibiotics, antifungals, or antiviral agents within 7 days before baseline participation in any study that would interfere with the current study. Fever (temperature\> 37.5 °C axillary or equivalent) during 48 hours prior the start of the study. Pathologies associated with immunodeficiency or cancer processes. Any concurrent dermatologic or medical conditions that may interfere with the investigators ability to assess the subject's response to the study drug or require the continued use of topical corticosteroids. Subjects who have received the schedule MMR vaccination during the study period or have received the last dose within three weeks prior the start of the study. Subjects who participates in any study that would interfere with the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 28 days | To evaluate the change in SCORAD from baseline to Day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | 14 days | To evaluate the change in SCORAD from baseline to Day 14 |
| Secondary endpoint | 14 and 28 days | To evaluate the change in itch NRS from baseline to Day 14 and Day 28 |
Contacts
CONTACTSofia Nordh, PhD
Outcome results
None listed