A Phase 3 interventional study of SanaCutan Basiscreme in Atopic Dermatitis and Infant, Newborn, sponsored by Infectopharm Arzneimittel GmbH. Status unknown at 10 sites in Germany. Open to participants aged Up to 21 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-24.
Sponsored by Infectopharm Arzneimittel GmbH · Phase 3, Interventional, and Prevention
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.
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).
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 360 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Infectopharm Arzneimittel GmbH is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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).
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).
Time frame: 0-6 months of age
Cumulative incidence of children with atopic dermatitis at the age of 12 and 16 weeks and 9, 12 and 6-12 months
Time frame: 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
Time frame: 0-12 months of age
Time to onset of atopic dermatitis at the age of 0-6, 6-12 and 0-12 months
Time frame: 0-12 months of age
Cumulative incidence and frequency of children with xerosis at the age of 6 and 12 months
Time frame: 0-12 months of age
Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age
Time frame: 0-12 months of age
Cumulative incidence and frequency of children with other types of eczema at 6 and 12 months of age
Time frame: 0-12 months of age
Severity of atopic dermatitis at the time of detection of (confirmed) atopic dermatitis up to the age of 12 and 16 weeks and 6, 9 and 12 months
Method: SCORAD (SCORing Atopic Dermatitis; 0-104 points; higher score indicates a more severe atopic dermatitis)
Time frame: 0-12 months of age
Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months
Positive/negative of Fx5 test and Sx1 test and - in case of a positive result - on a single allergen basis (with specific IgE value). The measures of sensitization and total IgE are performed for all children at the age of 6 months and again for children in the follow-up phase, if they are diagnosed with atopic dermatitis in this period of time.
Time frame: 0-12 months of age
Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to the age of 6 and 12 months
Time frame: 0-12 months of age
Drop-outs (with reasons) up to the age of 6 and 12 months
Time frame: 0-12 months of age
Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months
Time frame: 0-12 months of age
Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months
Time frame: 0-12 months of age
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2020 (actual). Primary completion is estimated for Dec 2023, 41 months after the start.
Of 149 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 28. This study's planned 41 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Infectopharm Arzneimittel GmbH