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

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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Timperley Medical Centre

Altrincham, WA14 5PF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Diprobase formulation (BAY987534)

Device

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

Primary outcomes

Number of participants with adverse event (AE)

Time frame: Up to 14 days
Severity of adverse event

Time frame: Up to 14 days
The intensity of an AE is classified according to the following categories:
- Mild
- Moderate
- Severe

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 22, 2018
Registry last updated: Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed