Atopic DermatitisPhase 3MOPADNCT04398758
Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood
A Phase 3 study testing SanaCutan Basiscreme in people with Atopic Dermatitis and Infant, Newborn, run by Infectopharm Arzneimittel GmbH at 10 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Infant, Newborn
- What is being tested?
- SanaCutan Basiscreme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 10 sitesGermany
- Study dates
- 22 Jul 2020to Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
Tanja Wehran, Dr. contact
10 sites in 1 country
Germany10 sites, 9 recruiting
- Active, not recruiting
Gemeinschaftspraxis Bauer, Gilb, von Bentzel
Augsburg, 86150
- Recruiting
Universitätsklinikum Augsburg
Augsburg, 86156
Michael Gerstlauer, Dr.
Anette Scharschinger, Dr
- Recruiting
Charité Universitätsmedizin
Berlin, 13353
Kirsten Beyer, Prof. Dr.
Susanne Lau, Prof. Dr.
- Recruiting
Evangelisches Klinikum Bethel
Bielefeld, 33617
Eckard Hamelmann, Prof. Dr.
Christina Schorlemer, Dr.
- Not yet recruiting
Katholisches Klinikum Bochum gGmbH
Bochum, 44791
Folke Brinkmann, Dr.
Anne Schlegtendal, Dr.
- Not yet recruiting
St. Marien-Hospital
Bonn, 53115
Lars Lange, Dr.
Sunhild Gernert, Dr.
- Recruiting
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217
Monika Gappa, Prof. Dr.
Meike Hartstein, Dr.
- Recruiting
Barmherzige Brüder Klinik St. Hedwig
Regensburg, 93049
Michael Kabesch, Prof. Dr.
Sebastian Kerzel, PD Dr.
- Recruiting
Gemeinschaftspraxis für Kinder- und Jugendmedizin
Tuttlingen, 78532
Ralph Maier, Dr.
Johannes Röhrenbach, Dr.
- Recruiting
Marien Hospital Wesel
Wesel, 46483
Cordula Koerner-Rettberg, Dr.
Simon Flümann, Dr.
About this study
Official title: 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
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.
Read the 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
- Being tested
- SanaCutan Basiscreme
- Keywords
- Skin care, Prevention, Risk factor, Interventional study, Multicentric
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SanaCutan BasiscremeDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Drug: SanaCutan Basiscreme |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0-6 months of age
Secondary outcomes (12)
Cumulative incidence of children with atopic dermatitis at the age of 12 and 16 weeks and 9, 12 and 6-12 months
Measured: 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
Measured: 0-12 months of age
Time to onset of atopic dermatitis at the age of 0-6, 6-12 and 0-12 months
Measured: 0-12 months of age
Cumulative incidence and frequency of children with xerosis at the age of 6 and 12 months
Measured: 0-12 months of age
Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age
Measured: 0-12 months of age
Cumulative incidence and frequency of children with other types of eczema at 6 and 12 months of age
Measured: 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)
Measured: 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.
Measured: 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
Measured: 0-12 months of age
Drop-outs (with reasons) up to the age of 6 and 12 months
Measured: 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
Measured: 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
Measured: 0-12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start22 Jul 2020
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infectopharm Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Responsible party
- Sponsor
- Investigators
- Kirsten Beyer, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398758
- Sponsor's protocol ID
- MOPAD
- Other IDs
- 2018-004762-33, 2018
- Acronym
- MOPAD
- Status last verified
- Jun 2022
- First submitted
- 18 May 2020
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04398758
- Acronym / sponsor ID
- MOPAD / MOPAD
- Conditions
- Atopic Dermatitis, Infant, Newborn
- Keywords
- Skin care, Prevention, Risk factor, Interventional study, Multicentric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Infectopharm Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SanaCutan BasiscremeChildren 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Acute or chronic diseases
- Acute fever (> 38.5 °C)
- Severe congenital malformations
- Hydrops fetalis
- Immunodeficiency (any kind)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SanaCutan BasiscremeIn 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). | Drug | Treatment group |
Primary outcome
Cumulative incidence of children with atopic dermatitis at 6 months of age
Time frame: 0-6 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).
12 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Wehran, Dr. contact
Kirsten Beyer, Prof. Dr. principal investigator
Charite University, Berlin, Germany
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SanaCutan Basiscreme in people with Atopic Dermatitis and Infant, Newborn, run by Infectopharm Arzneimittel GmbH at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanja Wehran, Dr. (studien@infectopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of children with atopic dermatitis at 6 months of age (time frame: 0-6 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.