NCT03441568

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

February 16, 2018

Last Update Submit

July 22, 2020

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • Number of participants with adverse event (AE)

    Up to 14 days

  • Severity of adverse event

    The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe

    Up to 14 days

Study Arms (1)

BAY987534

EXPERIMENTAL

Infants and children with quiescent atopic dermatitis

Device: Modified Diprobase formulation (BAY987534)

Interventions

Modified Diprobase formulation (BAY987534)DEVICE

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

BAY987534

Eligibility Criteria

Age6 Months - 48 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

West Timperley Medical Centre

Altrincham, WA14 5PF, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 22, 2018

Study Start

September 26, 2018

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

GB(1)