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

NCT ID: NCT03441568

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2019-08-02

Brief Summary

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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).

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BAY987534

Infants and children with quiescent atopic dermatitis

Group Type EXPERIMENTAL

Modified Diprobase formulation (BAY987534)

Intervention Type DEVICE

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

Interventions

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Modified Diprobase formulation (BAY987534)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West Timperley Medical Centre

Altrincham, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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2017-004334-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19690

Identifier Type: -

Identifier Source: org_study_id

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