NCT04398758

Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Infectopharm Arzneimittel GmbH · Industry
• Sex: All
• Age: 21 Days
• Healthy volunteers: Accepted

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).

Conditions

• Atopic Dermatitis
• Infant, Newborn

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-07-22
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2020-05-21
• Last updated: 2022-06-24

Locations

10 sites across 1 country: Germany