Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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

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Atopic Dermatitis Infant, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

SanaCutan Basiscreme

Intervention Type 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).

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes