In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
Not Applicable
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Device: Modified Diprobase formulation (BAY987534)
- Registration Number
- NCT03441568
- Lead Sponsor
- Bayer
- Brief Summary
To investigate the safety and tolerability of the modified Diprobase formulation over 14 days in infants and children with a history of Atopic Dermatitis (AD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BAY987534 Modified Diprobase formulation (BAY987534) Infants and children with quiescent atopic dermatitis
- Primary Outcome Measures
Name Time Method Number of participants with adverse event (AE) Up to 14 days Severity of adverse event Up to 14 days The intensity of an AE is classified according to the following categories:
* Mild
* Moderate
* Severe
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West Timperley Medical Centre
🇬🇧Altrincham, United Kingdom