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In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control

In-home Use Test of the New Modified Diprobase® Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03441568
Enrollment
40
Registered
2018-02-22
Start date
2018-09-26
Completion date
2019-08-02
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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).

Interventions

DEVICEModified Diprobase formulation (BAY987534)

The modified Diprobase formulation will be applied topically twice daily over 14 days on the whole body and face.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 48 Months
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with adverse event (AE)Up to 14 days—
Severity of adverse eventUp to 14 daysThe intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026