Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

NCT04398758 | Unknown Phase 3

• 2 other identifiers: MOPAD2018-004762-33
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 10

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.

Conditions

Atopic Dermatitis; Infant, Newborn

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  0-6 months of age

Secondary Outcomes (12)

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

  0-12 months of age

• 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

  0-12 months of age

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

  0-12 months of age

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

  0-12 months of age

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

  0-12 months of age

Study Arms (2)

Treatment group

EXPERIMENTAL

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.

Drug: SanaCutan Basiscreme

Control group

NO INTERVENTION

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.

Interventions

SanaCutan Basiscreme DRUG

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).

Treatment group

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Infectopharm Arzneimittel GmbH: lead
• Gesellschaft für Therapieforschung mbH: collaborator

Study Sites (10)

Gemeinschaftspraxis Bauer, Gilb, von Bentzel

Augsburg, 86150, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

RECRUITING

Charité Universitätsmedizin

Berlin, 13353, Germany

RECRUITING

Evangelisches Klinikum Bethel

Bielefeld, 33617, Germany

RECRUITING

Katholisches Klinikum Bochum gGmbH

Bochum, 44791, Germany

NOT YET RECRUITING

St. Marien-Hospital

Bonn, 53115, Germany

NOT YET RECRUITING

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

RECRUITING

Barmherzige Brüder Klinik St. Hedwig

Regensburg, 93049, Germany

RECRUITING

Gemeinschaftspraxis für Kinder- und Jugendmedizin

Tuttlingen, 78532, Germany

RECRUITING

Marien Hospital Wesel

Wesel, 46483, Germany

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Kirsten Beyer, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Wehran, Dr.

CONTACT

studien@infectopharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: July 22, 2020
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)