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Atopic Dermatitis in Atopy Predisposed Infants (ADAPI)

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

standardized skin care regimen

About this trial

This is an interventional prevention trial for Dermatitis, Atopic focused on measuring Dermatitis, atopic, prevention and control, Infant, Skin care, randomized controlled trial

Eligibility Criteria

undefined - 14 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Sites / Locations

Charite Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention: standardized skin care regimen

Control

Arm Description

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.

In the control group no predetermined or standardized skin care regimen is prescribed.

Outcomes

Primary Outcome Measures

Cumulative incidence of atopic dermatitis

Cumulative incidence of AD at week 52, with AD diagnosis based on the criteria by Simpson et al. 2012

Secondary Outcome Measures

Cumulative incidence of atopic dermatitis

AD incidence density

Eczema Area and Severity Index (EASI)

Infant Dermatitis Quality of Life (IDQoL)

Transepidermal water loss (TEWL) on the midvolar forearm

Skin surface pH on the midvolar forearm

Stratum Corneum Hydration (SCH) on the forearm

Full Information

NCT ID

NCT02906475

First Posted

September 15, 2016

Last Updated

April 20, 2021

Sponsor

HiPP GmbH & Co. Vertrieb KG

Collaborators

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02906475

Brief Title

Atopic Dermatitis in Atopy Predisposed Infants

Acronym

ADAPI

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HiPP GmbH & Co. Vertrieb KG

Collaborators

Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

Dermatitis, atopic, prevention and control, Infant, Skin care, randomized controlled trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention: standardized skin care regimen

Arm Type

Other

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

In the control group no predetermined or standardized skin care regimen is prescribed.

Intervention Type

Other

Intervention Name(s)

standardized skin care regimen

Intervention Description

Application of a standardized daily skin care regimen: milk lotion once daily and application of addendum for bathing as needed

Primary Outcome Measure Information:

Title

Cumulative incidence of atopic dermatitis

Description

Cumulative incidence of AD at week 52, with AD diagnosis based on the criteria by Simpson et al. 2012

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Cumulative incidence of atopic dermatitis

Time Frame

24 months

Title

AD incidence density

Time Frame

12 months

Title

AD incidence density

Time Frame

24 months

Title

Eczema Area and Severity Index (EASI)

Time Frame

12 months

Title

Eczema Area and Severity Index (EASI)

Time Frame

24 months

Title

Infant Dermatitis Quality of Life (IDQoL)

Time Frame

12 months

Title

Infant Dermatitis Quality of Life (IDQoL)

Time Frame

24 months

Title

Transepidermal water loss (TEWL) on the midvolar forearm

Time Frame

at ages of 14 days, 1, 3, 6, 12 months and 2 years

Title

Skin surface pH on the midvolar forearm

Time Frame

at ages of 14 days, 1, 3, 6, 12 months and 2 years

Title

Stratum Corneum Hydration (SCH) on the forearm

Time Frame

at ages of 14 days, 1, 3, 6, 12 months and 2 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrike Blume-Peytavi, Prof. Dr.

Organizational Affiliation

Charite Universitätsmedizin Berlin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charite Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22424882

Citation

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.

Results Reference

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Atopic Dermatitis in Atopy Predisposed Infants

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