Efficacy and Tolerability of a Probiotic Ointment
ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorBioGaia AB
About this trial
This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic Ointment
Other interventionProbiotic ointment
Comparator product
Other interventionBasic lotion
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Probiotic OintmentExperimental treatment 1 intervention
Group B: Comparator ProductExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Endpoint
To evaluate the change in SCORAD from baseline to Day 28.
Time frame
28 daysSecondary outcomes
1
Secondary Endpoint
To evaluate the change in SCORAD from baseline to Day 14
Time frame
14 days2
Secondary Endpoint
To evaluate the change in local SCORAD from baseline to Day 14 and Day 28
Time frame
14 and 28 days3
Secondary Endpoint
To evaluate the change in skin barrier function (TEWL) from baseline to Day 14 and Day 28
Time frame
14 and 28 days4
Secondary Endpoint
To evaluate the change in POEM score from baseline to Day 14 and Day 28
Time frame
14 and 28 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
BioGaia AB
Lead sponsor
Zurko Research
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: