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Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood (MOPAD)

Primary Purpose

Atopic Dermatitis, Infant, Newborn

Status

Recruiting

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

SanaCutan Basiscreme

About this trial

This is an interventional prevention trial for Atopic Dermatitis focused on measuring Skin care, Prevention, Risk factor, Interventional study, Multicentric

Eligibility Criteria

undefined - 21 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy newborns (male or female)
Age < 3 weeks (≤ 21st day of life)
High familial risk of atopic dermatitis in the form of at least one first-degree relative (parent or sibling) with a medically diagnosed atopic dermatitis in the medical history
Written consent of all guardians

Exclusion Criteria:

Acute or chronic diseases
Acute fever (> 38.5 °C)
Severe congenital malformations
Hydrops fetalis
Immunodeficiency (any kind)
Severe genetic skin diseases or skin conditions that make the use of skin creams unsuitable
Corticoid or calcineurin inhibitor use or Ciclosporin intake
Preterm birth (< 37 weeks)
Known hypersensitivity to one of the ingredients of the SanaCutan Basiscreme
Restricted legal capacity of the guardians
Inability of the guardians to understand the study instructions
Obvious unreliability or lack of cooperation of the guardians
Known alcohol, medicine or drug dependency of the guardians
Dependence of the child or guardians on the sponsor or the investigator
Previous participation in another clinical trial (since birth)
Previous participation in this study

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Control group

Arm Description

Children of the treatment group receive the cream "SanaCutan Basiscreme". The cream's main ingredients are white soft paraffin and liquid paraffin and it is already approved for the treatment of several skin diseases due to its skin care effect.

Children of the control group should avoid regular skincare applications. Skincare is not prohibited, however, it is recommended to use products only in urgent cases.

Outcomes

Primary Outcome Measures

Cumulative incidence of children with atopic dermatitis at 6 months of age

A confirmed atopic dermatitis is present if an atopic dermatitis is diagnosed in at least 2 examinations at intervals of at least 4 weeks (preliminary diagnosis + proof of chronification). The primary objective is achieved when the cumulative incidence of children with atopic dermatitis in the treatment group at 6 months of age is significantly lower than in the control group without predetermined treatment (p < 0.05).

Secondary Outcome Measures

Cumulative incidence of children with atopic dermatitis at the age of 12 and 16 weeks and 9, 12 and 6-12 months

Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed) at 12 and 16 weeks and 6, 9 and 12 months

Time to onset of atopic dermatitis at the age of 0-6, 6-12 and 0-12 months

Cumulative incidence and frequency of children with xerosis at the age of 6 and 12 months

Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age

Cumulative incidence and frequency of children with other types of eczema at 6 and 12 months of age

Severity of atopic dermatitis at the time of detection of (confirmed) atopic dermatitis up to the age of 12 and 16 weeks and 6, 9 and 12 months

Method: SCORAD (SCORing Atopic Dermatitis; 0-104 points; higher score indicates a more severe atopic dermatitis)

Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months

Positive/negative of Fx5 test and Sx1 test and - in case of a positive result - on a single allergen basis (with specific IgE value). The measures of sensitization and total IgE are performed for all children at the age of 6 months and again for children in the follow-up phase, if they are diagnosed with atopic dermatitis in this period of time.

Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to the age of 6 and 12 months

Drop-outs (with reasons) up to the age of 6 and 12 months

Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months

Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months

Full Information

NCT ID

NCT04398758

First Posted

May 18, 2020

Last Updated

June 23, 2022

Sponsor

Infectopharm Arzneimittel GmbH

Collaborators

Gesellschaft für Therapieforschung mbH

1. Study Identification

Unique Protocol Identification Number

NCT04398758

Brief Title

Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

Acronym

MOPAD

Official Title

Prospective, Randomized, Non-treatment-controlled, Investigator-blinded, Multicenter Study on the Prophylaxis of Early Childhood Symptoms of Atopic Dermatitis in High-risk Children by Continuous Application of a Moisturizing Barrier-stabilizing Skin Cream

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Infectopharm Arzneimittel GmbH

Collaborators

Gesellschaft für Therapieforschung mbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In this study, it will be investigated if symptoms of atopic dermatitis of children with high familial risk will be delayed beyond the 6th or even 12th month of life by applying the SanaCutan Basiscreme.

Detailed Description

Enrolled healthy newborns with high risk for atopic dermatitis will be 1:1 randomised into treatment and control group. The treatment group receives the SanaCutan Basiscreme for twice daily skin application until the age of 6 months (main phase; half of them until the age of 12 months (main + follow-up phase)), whereas the control group should avoid skin care products. Guardians of both groups are requested to document all applied skin care products in a diary. In regular visits at the study sites, a blinded physician investigates the skin of the children. In case of an atopic dermatitis (= atopic dermatitis has to be diagnosed in at least two visits with an interval of at least four weeks), the severity will be examined (SCORAD) and the treatment with SanaCutan Basiscreme will be terminated. All children will be followed up until the age of 6 months (end of main phase). This is the time when a blood test will be conducted to determine sensitization against food and inhalant allergens and total IgE. If children do not develop an atopic dermatitis in the main phase, the study continues until they receive the diagnosis (up to a maximum of 12 months, end of follow-up phase).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis, Infant, Newborn

Keywords

Skin care, Prevention, Risk factor, Interventional study, Multicentric

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Prospective, randomized, non-treatment-controlled, investigator-blinded, multicenter, 2-arm parallel group study (main phase: from inclusion until 6 months of age with treatment group and control group (without treatment) according to 1:1 randomisation; follow-up phase: 6-12 months of age in which only half of the children from the treatment group is treated according to initial 1:1 randomisation)

Masking

Investigator

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Children of the control group should avoid regular skincare applications. Skincare is not prohibited, however, it is recommended to use products only in urgent cases.

Intervention Type

Drug

Intervention Name(s)

SanaCutan Basiscreme

Intervention Description

In this study, the SanaCutan Basiscreme will be used as a cream for twice daily application on the whole body (eyes and mucous membranes have to be omitted) for a duration of 6 months (main phase) or 12 months (main + follow-up phase) or less (if the child develops atopic dermatitis).

Primary Outcome Measure Information:

Title

Cumulative incidence of children with atopic dermatitis at 6 months of age

Description

Time Frame

0-6 months of age

Secondary Outcome Measure Information:

Title

Cumulative incidence of children with atopic dermatitis at the age of 12 and 16 weeks and 9, 12 and 6-12 months

Time Frame

0-12 months of age

Title

Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed) at 12 and 16 weeks and 6, 9 and 12 months

Time Frame

0-12 months of age

Title

Time to onset of atopic dermatitis at the age of 0-6, 6-12 and 0-12 months

Time Frame

0-12 months of age

Title

Cumulative incidence and frequency of children with xerosis at the age of 6 and 12 months

Time Frame

0-12 months of age

Title

Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age

Time Frame

0-12 months of age

Title

Cumulative incidence and frequency of children with other types of eczema at 6 and 12 months of age

Time Frame

0-12 months of age

Title

Severity of atopic dermatitis at the time of detection of (confirmed) atopic dermatitis up to the age of 12 and 16 weeks and 6, 9 and 12 months

Description

Method: SCORAD (SCORing Atopic Dermatitis; 0-104 points; higher score indicates a more severe atopic dermatitis)

Time Frame

0-12 months of age

Title

Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months

Description

Time Frame

0-12 months of age

Title

Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to the age of 6 and 12 months

Time Frame

0-12 months of age

Title

Drop-outs (with reasons) up to the age of 6 and 12 months

Time Frame

0-12 months of age

Title

Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months

Time Frame

0-12 months of age

Title

Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months

Time Frame

0-12 months of age

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy newborns (male or female) Age < 3 weeks (≤ 21st day of life) High familial risk of atopic dermatitis in the form of at least one first-degree relative (parent or sibling) with a medically diagnosed atopic dermatitis in the medical history Written consent of all guardians Exclusion Criteria: Acute or chronic diseases Acute fever (> 38.5 °C) Severe congenital malformations Hydrops fetalis Immunodeficiency (any kind) Severe genetic skin diseases or skin conditions that make the use of skin creams unsuitable Corticoid or calcineurin inhibitor use or Ciclosporin intake Preterm birth (< 37 weeks) Known hypersensitivity to one of the ingredients of the SanaCutan Basiscreme Restricted legal capacity of the guardians Inability of the guardians to understand the study instructions Obvious unreliability or lack of cooperation of the guardians Known alcohol, medicine or drug dependency of the guardians Dependence of the child or guardians on the sponsor or the investigator Previous participation in another clinical trial (since birth) Previous participation in this study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tanja Wehran, Dr.

studien@infectopharm.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kirsten Beyer, Prof. Dr.

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gemeinschaftspraxis Bauer, Gilb, von Bentzel

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Universitätsklinikum Augsburg

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Gerstlauer, Dr.

First Name & Middle Initial & Last Name & Degree

Anette Scharschinger, Dr

Facility Name

Charité Universitätsmedizin

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kirsten Beyer, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Susanne Lau, Prof. Dr.

Facility Name

Evangelisches Klinikum Bethel

City

Bielefeld

ZIP/Postal Code

33617

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eckard Hamelmann, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Christina Schorlemer, Dr.

Facility Name

Katholisches Klinikum Bochum gGmbH

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Folke Brinkmann, Dr.

First Name & Middle Initial & Last Name & Degree

Anne Schlegtendal, Dr.

Facility Name

St. Marien-Hospital

City

Bonn

ZIP/Postal Code

53115

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lars Lange, Dr.

First Name & Middle Initial & Last Name & Degree

Sunhild Gernert, Dr.

Facility Name

Evangelisches Krankenhaus Düsseldorf

City

Düsseldorf

ZIP/Postal Code

40217

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Monika Gappa, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Meike Hartstein, Dr.

Facility Name

Barmherzige Brüder Klinik St. Hedwig

City

Regensburg

ZIP/Postal Code

93049

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Kabesch, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Sebastian Kerzel, PD Dr.

Facility Name

Gemeinschaftspraxis für Kinder- und Jugendmedizin

City

Tuttlingen

ZIP/Postal Code

78532

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ralph Maier, Dr.

First Name & Middle Initial & Last Name & Degree

Johannes Röhrenbach, Dr.

Facility Name

Marien Hospital Wesel

City

Wesel

ZIP/Postal Code

46483

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cordula Koerner-Rettberg, Dr.

First Name & Middle Initial & Last Name & Degree

Simon Flümann, Dr.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

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Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood (MOPAD)

Atopic Dermatitis, Infant, Newborn

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial