Dermatitis, AtopicADAPINCT02906475
Atopic Dermatitis in Atopy Predisposed Infants
A study testing standardized skin care regimen in people with Dermatitis, Atopic, run by HiPP GmbH & Co. Vertrieb KG at 1 site in Germany.
Trial summary
The primary objective of this study is to investigate the effectiveness of a standardized skin care regimen using a milk lotion once daily and a bathing addendum as needed during the first 52 weeks of life on the development of atopic Dermatitis (AD) compared to no structured skin care regimen in infants with atopic… Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- standardized skin care regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Dec 2020
- Phase
- Interventional
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent (by both parents or legal representatives)
- Healthy term newborns (gestational age: completed 37 weeks) born by mothers aged 18-45 years
- Birth weight between 2.500 - 4.500 g
- Age at enrolment 14 days
- Infants at enhanced risk for developing AD (at least one parent or sibling with physician-diagnosed AD, asthma or allergic rhinitis/rhino conjunctivitis as reported by at least by one parent but in otherwise good overall health
- Infant Nutrition: breastfeeding or cow's-milk based infant formula (including Hypoallergenic (HA) - based formula) feeding or combination
- Phototype I, II, III or IV according to the Fitzpatrick classification.
Who cannot join
- Serious acquired or congenital diseases
- Hydrops fetalis
- Preterm children (< completed 37th week of gestation)
- Weight at birth < 2500 g or > 4500 g
- Significant dermatitis at birth except seborrheic dermatitis on the scalp ("cradle cap")
- Dermatological conditions influencing the study parameters, besides benign transient neonatal diseases
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- Any immunodeficiency disorder
- Any severe genetic skin disorder
- Any other serious condition that would make the use of skin care products inadvisable
- Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess
- Participation in another clinical study
- Reason to presume that the parents are unable to meet the study plan requirements
- Nutrition: other than breastfeeding or cow's-milk based infant formula (e.g. soybased, goat-milk based formula etc.)
- History of allergy or intolerance to investigational product's ingredient(s) of at least one subject's parent
- Current topical or systemic drug treatment
- Maternal antibiotic therapy in breastfed newborns
- Infants of mothers supplementing probiotics during pregnancy and/or breastfeeding on a regular basis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Pragmatic Parallel Group Trial to Investigate the Effectiveness of a Standardized Skin Care Regimen to Prevent the Development of Atopic Dermatitis in Atopy Predisposed Infants
The primary objective of this study is to investigate the effectiveness of a standardized skin care regimen using a milk lotion once daily and a bathing addendum as needed during the first 52 weeks of life on the development of atopic Dermatitis (AD) compared to no structured skin care regimen in infants with atopic predisposition. Secondary objectives are to investigate the influence of a structured skin care regimen on the development of AD in the second year of life and the skin barrier function up to the infants' age of 2 years.
Read the detailed description
Atopic dermatitis is the most common cutaneous disease in childhood. First manifestations of AD usually appear early in life after the 3rd month of life and often precede other allergic diseases such as asthma or allergic rhinitis. AD affects over 15% of children up to school age in Germany and has a substantial impact on the lives and life quality of both the child and its family. Taking into account the burden on health-care resources, the impact on the quality of life of patients and their caregivers, together with increasing evidence that AD may progress to other allergic phenotypes, there is a clear need to improve disease prevention. Due to the childhood prevalence of the disease, prevention is focused on the postnatal period. It is recognized that prevention should start as soon as possible. Current studies suggest that epidermal barrier impairment is an important factor for the development of AD and other allergic diseases, with the gene encoding the filament-binding protein filaggrin (FLG) being the most widely replicated and most significant gene to influence atopic diseases. Currently, no standardized recommendations for preventive therapies exist for AD. Pilot studies have focused on interventions to enhance skin barrier function. Daily skin care with an emollient early after birth is considered to reduce the risk of atopic dermatitis in infants.
The study will be divided in 2 parts: The main study (Interventional period) lasts up to the child´s age of one year (52 weeks of life) and the follow-up period up to the second birthday.
- Conditions
- Dermatitis, Atopic
- Being tested
- standardized skin care regimen
- Keywords
- Dermatitis, atopic, prevention and control, Infant, Skin care, randomized controlled trial
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized skin care regimenOther
Application of a standardized daily skin care regimen:
- milk lotion once daily and
- application of addendum for bathing as needed
| Study group | Role | What they receive |
|---|---|---|
| Intervention: standardized skin care regimen | Other | Intervention: The milk lotion will be applied once daily on the total body including the face by the parents or care givers at home. If bathing is needed, the bathing addendum is used in addition to water. Receives: Other: standardized skin care regimen |
| Control | No intervention | In the control group no predetermined or standardized skin care regimen is prescribed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of atopic dermatitis
Cumulative incidence of AD at week 52, with AD diagnosis based on the criteria by Simpson et al. 2012
Measured: 12 months
Secondary outcomes (10)
Cumulative incidence of atopic dermatitis
Measured: 24 months
AD incidence density
Measured: 12 months
AD incidence density
Measured: 24 months
Eczema Area and Severity Index (EASI)
Measured: 12 months
Eczema Area and Severity Index (EASI)
Measured: 24 months
Infant Dermatitis Quality of Life (IDQoL)
Measured: 12 months
Infant Dermatitis Quality of Life (IDQoL)
Measured: 24 months
Transepidermal water loss (TEWL) on the midvolar forearm
Measured: at ages of 14 days, 1, 3, 6, 12 months and 2 years
Skin surface pH on the midvolar forearm
Measured: at ages of 14 days, 1, 3, 6, 12 months and 2 years
Stratum Corneum Hydration (SCH) on the forearm
Measured: at ages of 14 days, 1, 3, 6, 12 months and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Ulrike Blume-Peytavi, Prof. Dr., Principal investigator, Charite Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906475
- Sponsor's protocol ID
- 508276
- Acronym
- ADAPI
- Status last verified
- Apr 2021
- First submitted
- 15 Sep 2016
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Simpson EL, Keck LE, Chalmers JR, Williams HC. How should an incident case of atopic dermatitis be defined? A systematic review of primary prevention studies. J Allergy Clin Immunol. 2012 Jul;130(1):137-44. doi: 10.1016/j.jaci.2012.01.075. Epub 2012 Mar 15.
PubMed 22424882
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pragmatic Parallel Group Trial to Investigate the Effectiveness of a Standardized Skin Care Regimen to Prevent the Development of Atopic Dermatitis in Atopy Predisposed Infants
- ClinicalTrials.gov ID
- NCT02906475
- Acronym / sponsor ID
- ADAPI / 508276
- Conditions
- Dermatitis, Atopic
- Keywords
- Dermatitis, atopic, prevention and control, Infant, Skin care, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KGIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 20 Sep 2016 (estimated)
- 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.
The primary objective of this study is to investigate the effectiveness of a standardized skin care regimen using a milk lotion once daily and a bathing addendum as needed during the first 52 weeks of life on the development of atopic Dermatitis (AD) compared to no structured skin care regimen in infants with atopic predisposition. Secondary objectives are to investigate the influence of a structured skin care regimen on the development of AD in the second year of life and the skin barrier function up to the infants' age of 2 years.
Detailed description
Atopic dermatitis is the most common cutaneous disease in childhood. First manifestations of AD usually appear early in life after the 3rd month of life and often precede other allergic diseases such as asthma or allergic rhinitis. AD affects over 15% of children up to school age in Germany and has a substantial impact on the lives and life quality of both the child and its family. Taking into account the burden on health-care resources, the impact on the quality of life of patients and their caregivers, together with increasing evidence that AD may progress to other allergic phenotypes, there is a clear need to improve disease prevention. Due to the childhood prevalence of the disease, prevention is focused on the postnatal period. It is recognized that prevention should start as soon as possible. Current studies suggest that epidermal barrier impairment is an important factor for the development of AD and other allergic diseases, with the gene encoding the filament-binding protein filaggrin (FLG) being the most widely replicated and most significant gene to influence atopic diseases. Currently, no standardized recommendations for preventive therapies exist for AD. Pilot studies have focused on interventions to enhance skin barrier function. Daily skin care with an emollient early after birth is considered to reduce the risk of atopic dermatitis in infants.
The study will be divided in 2 parts: The main study (Interventional period) lasts up to the child´s age of one year (52 weeks of life) and the follow-up period up to the second birthday.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: standardized skin care regimen | Other | Other: standardized skin care regimenIntervention: The milk lotion will be applied once daily on the total body including the face by the parents or care givers at home. If bathing is needed, the bathing addendum is used in addition to water. |
| Control | No intervention | –In the control group no predetermined or standardized skin care regimen is prescribed. |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Written informed consent (by both parents or legal representatives)
- Healthy term newborns (gestational age: completed 37 weeks) born by mothers aged 18-45 years
- Birth weight between 2.500 - 4.500 g
- Age at enrolment 14 days
- Infants at enhanced risk for developing AD (at least one parent or sibling with physician-diagnosed AD, asthma or allergic rhinitis/rhino conjunctivitis as reported by at least by one parent but in otherwise good overall health
Key exclusion criteria (17 listed)
- Serious acquired or congenital diseases
- Hydrops fetalis
- Preterm children (< completed 37th week of gestation)
- Weight at birth < 2500 g or > 4500 g
- Significant dermatitis at birth except seborrheic dermatitis on the scalp ("cradle cap")
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 |
|---|---|---|
| standardized skin care regimenApplication of a standardized daily skin care regimen: * milk lotion once daily and * application of addendum for bathing as needed | Other | Intervention: standardized skin care regimen |
Primary outcome
Cumulative incidence of atopic dermatitis
Time frame: 12 months
Cumulative incidence of AD at week 52, with AD diagnosis based on the criteria by Simpson et al. 2012
10 secondary outcomes
Cumulative incidence of atopic dermatitis
Time frame: 24 months
AD incidence density
Time frame: 12 months
AD incidence density
Time frame: 24 months
Eczema Area and Severity Index (EASI)
Time frame: 12 months
Eczema Area and Severity Index (EASI)
Time frame: 24 months
Infant Dermatitis Quality of Life (IDQoL)
Time frame: 12 months
Infant Dermatitis Quality of Life (IDQoL)
Time frame: 24 months
Transepidermal water loss (TEWL) on the midvolar forearm
Time frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years
Skin surface pH on the midvolar forearm
Time frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years
Stratum Corneum Hydration (SCH) on the forearm
Time frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Background: PubMed 22424882Simpson EL, Keck LE, Chalmers JR, Williams HC. How should an incident case of atopic dermatitis be defined? A systematic review of primary prevention studies. J Allergy Clin Immunol. 2012 Jul;130(1):137-44. doi: 10.1016/j.jaci.2012.01.075. Epub 2012 Mar 15.
- 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.
Ulrike Blume-Peytavi, Prof. Dr. principal investigator
Charite Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized skin care regimen in people with Dermatitis, Atopic, run by HiPP GmbH & Co. Vertrieb KG at 1 site 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of atopic dermatitis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906475, which also lists 1 linked publication.
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 21 Apr 2021.