Atopic Dermatitis in Atopy Predisposed Infants (ADAPI)

April 20, 2021 updated by: HiPP GmbH & Co. Vertrieb KG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent (by both parents or legal representatives)
  2. Healthy term newborns (gestational age: completed 37 weeks) born by mothers aged 18-45 years
  3. Birth weight between 2.500 - 4.500 g
  4. Age at enrolment 14 days
  5. 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
  6. Infant Nutrition: breastfeeding or cow's-milk based infant formula (including Hypoallergenic (HA) - based formula) feeding or combination
  7. Phototype I, II, III or IV according to the Fitzpatrick classification.

Exclusion Criteria:

  1. Serious acquired or congenital diseases
  2. Hydrops fetalis
  3. Preterm children (< completed 37th week of gestation)
  4. Weight at birth < 2500 g or > 4500 g
  5. Significant dermatitis at birth except seborrheic dermatitis on the scalp ("cradle cap")
  6. Dermatological conditions influencing the study parameters, besides benign transient neonatal diseases
  7. Any immunodeficiency disorder
  8. Any severe genetic skin disorder
  9. Any other serious condition that would make the use of skin care products inadvisable
  10. 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
  11. Participation in another clinical study
  12. Reason to presume that the parents are unable to meet the study plan requirements
  13. Nutrition: other than breastfeeding or cow's-milk based infant formula (e.g. soybased, goat-milk based formula etc.)
  14. History of allergy or intolerance to investigational product's ingredient(s) of at least one subject's parent
  15. Current topical or systemic drug treatment
  16. Maternal antibiotic therapy in breastfed newborns
  17. Infants of mothers supplementing probiotics during pregnancy and/or breastfeeding on a regular basis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention: standardized skin care regimen
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.
Other: standardized skin care regimen

Application of a standardized daily skin care regimen:

  • milk lotion once daily and
  • application of addendum for bathing as needed
No Intervention: Control
In the control group no predetermined or standardized skin care regimen is prescribed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of atopic dermatitis
Time Frame: 24 months
24 months
AD incidence density
Time Frame: 12 months
12 months
AD incidence density
Time Frame: 24 months
24 months
Eczema Area and Severity Index (EASI)
Time Frame: 12 months
12 months
Eczema Area and Severity Index (EASI)
Time Frame: 24 months
24 months
Infant Dermatitis Quality of Life (IDQoL)
Time Frame: 12 months
12 months
Infant Dermatitis Quality of Life (IDQoL)
Time Frame: 24 months
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
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
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
at ages of 14 days, 1, 3, 6, 12 months and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HiPP GmbH & Co. Vertrieb KG

Collaborators

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Ulrike Blume-Peytavi, Prof. Dr., Charité Universitätsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 508276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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