Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

Last updated: June 23, 2022
Sponsor: Infectopharm Arzneimittel GmbH
Overall Status: Active - Recruiting

Phase

3

Condition

Atopic Dermatitis

Dermatitis, Atopic

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT04398758
MOPAD
2018-004762-33
  • Ages < 21
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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-degreerelative (parent or sibling) with a medically diagnosed atopic dermatitis in themedical history
  • Written consent of all guardians

Exclusion

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 creamsunsuitable
  • 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

Study Design

Total Participants: 360
Study Start date:
July 22, 2020
Estimated Completion Date:
June 30, 2024

Study 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).

Connect with a study center

  • Gemeinschaftspraxis Bauer, Gilb, von Bentzel

    Augsburg, 86150
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg, 86156
    Germany

    Active - Recruiting

  • Charité Universitätsmedizin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Evangelisches Klinikum Bethel

    Bielefeld, 33617
    Germany

    Active - Recruiting

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791
    Germany

    Site Not Available

  • St. Marien-Hospital

    Bonn, 53115
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf, 40217
    Germany

    Active - Recruiting

  • Barmherzige Brüder Klinik St. Hedwig

    Regensburg, 93049
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis für Kinder- und Jugendmedizin

    Tuttlingen, 78532
    Germany

    Active - Recruiting

  • Marien Hospital Wesel

    Wesel, 46483
    Germany

    Active - Recruiting

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