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

Bayer

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Device: Modified Diprobase formulation (BAY987534)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03441568

2017-004334-29 (EudraCT Number)

19690

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 6 to 48 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

BAY987534

Experimental group

Description:

Infants and children with quiescent atopic dermatitis

Treatment:

Device: Modified Diprobase formulation (BAY987534)