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Atopic Dermatitis in Atopy Predisposed Infants (ADAPI)

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ClinicalTrials.gov Identifier: NCT02906475
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
HiPP GmbH & Co. Vertrieb KG

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Other: standardized skin care regimen Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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 Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cumulative incidence of atopic dermatitis [ Time Frame: 24 months ]
  2. AD incidence density [ Time Frame: 12 months ]
  3. AD incidence density [ Time Frame: 24 months ]
  4. Eczema Area and Severity Index (EASI) [ Time Frame: 12 months ]
  5. Eczema Area and Severity Index (EASI) [ Time Frame: 24 months ]
  6. Infant Dermatitis Quality of Life (IDQoL) [ Time Frame: 12 months ]
  7. Infant Dermatitis Quality of Life (IDQoL) [ Time Frame: 24 months ]
  8. Transepidermal water loss (TEWL) on the midvolar forearm [ Time Frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years ]
  9. Skin surface pH on the midvolar forearm [ Time Frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years ]
  10. Stratum Corneum Hydration (SCH) on the forearm [ Time Frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years ]


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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906475


Locations
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Germany
Charite Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
HiPP GmbH & Co. Vertrieb KG
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Ulrike Blume-Peytavi, Prof. Dr. Charite Universitätsmedizin Berlin

Publications:
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Responsible Party: HiPP GmbH & Co. Vertrieb KG
ClinicalTrials.gov Identifier: NCT02906475     History of Changes
Other Study ID Numbers: 508276
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by HiPP GmbH & Co. Vertrieb KG:
Dermatitis, atopic
prevention and control
Infant
Skin care
randomized controlled trial
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases