Back to resultsIn-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Modified Diprobase formulation (BAY987534)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
- Children with normal or dry skin and a history of mild to moderate AD, but without any signs or symptoms within the last month prior to enrollment
- Skin type I - VI according to Fitzpatrick skin classification
- Aged 6 months to 48 months
Sites / Locations
- West Timperley Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BAY987534
Arm Description
Infants and children with quiescent atopic dermatitis
Outcomes
Primary Outcome Measures
Number of participants with adverse event (AE)
Severity of adverse event
The intensity of an AE is classified according to the following categories:
Mild
Moderate
Severe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03441568
Brief Title
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
Official Title
In-home Use Test of the New Modified Diprobase® Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAY987534
Arm Type
Experimental
Arm Description
Infants and children with quiescent atopic dermatitis
Intervention Type
Device
Intervention Name(s)
Modified Diprobase formulation (BAY987534)
Intervention Description
The modified Diprobase formulation will be applied topically twice daily over 14 days on the whole body and face.
Primary Outcome Measure Information:
Title
Number of participants with adverse event (AE)
Time Frame
Up to 14 days
Title
Severity of adverse event
Description
The intensity of an AE is classified according to the following categories:
Mild
Moderate
Severe
Time Frame
Up to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Children with normal or dry skin and a history of mild to moderate AD, but without any signs or symptoms within the last month prior to enrollment
Skin type I - VI according to Fitzpatrick skin classification
Aged 6 months to 48 months
Facility Information:
Facility Name
West Timperley Medical Centre
City
Altrincham
ZIP/Postal Code
WA14 5PF
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
Learn more about this trial
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
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