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Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

NCT04398758 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-06-24

No results posted yet for this study

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

Interventions

DRUG

SanaCutan Basiscreme

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).

Sponsors & Collaborators

  • Gesellschaft für Therapieforschung mbH

    collaborator INDUSTRY

  • Infectopharm Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Kirsten Beyer, Prof. Dr. · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
21 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04398758 on ClinicalTrials.gov