check_circleStudy Completed

Atopic dermatitis

Bayer Identifier:

19690

ClinicalTrials.gov Identifier:

NCT03441568

EudraCT Number:

2017-004334-29

EU CT Number:

Not Available
In-home use test of the new modified Diprobase formulation to assess the safety and tolerability in infants and children under physician’s control

Trial purpose

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).

Key Participants Requirements

Sex

All

Age

6 - 48 Months
  • - 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

Trial summary

Enrollment Goal
40
Trial Dates
September 2018 - August 2019
Phase
N/A
Could I Receive a placebo
No
Products
Diprobase (BAY987534)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
West Timperley Medical CentreAltrincham, WA14 5PF, United Kingdom

Primary Outcome

  • Number of participants with adverse event (AE)
    date_rangeTime Frame:
    Up to 14 days
  • Severity of adverse event
    The intensity of an AE is classified according to the following categories: • Mild • Moderate • Severe
    date_rangeTime Frame:
    Up to 14 days

Trial design

In-home use test of the new modified Diprobase® formulation to assess the safety and tolerability in infants and children under physician’s control
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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