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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03441568
Other study ID # 19690
Secondary ID 2017-004334-29
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2018
Est. completion date August 2, 2019

Study information

Verified date July 2020
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2, 2019
Est. primary completion date August 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 48 Months
Eligibility - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Modified Diprobase formulation (BAY987534)
The modified Diprobase formulation will be applied topically twice daily over 14 days on the whole body and face.

Locations

Country Name City State
United Kingdom West Timperley Medical Centre Altrincham

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse event (AE) Up to 14 days
Primary Severity of adverse event The intensity of an AE is classified according to the following categories:
Mild
Moderate
Severe
Up to 14 days
See also
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