Clinical trial NCT02906475: Atopic Dermatitis in Atopy Predisposed Infants
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
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Dermatitis, atopic
prevention and control
Infant
Skin care
randomized controlled trial
Lead sponsor: HiPP GmbH & Co. Vertrieb KG
Sponsor class: INDUSTRY
Collaborators: name: Charite University, Berlin, Germany
First posted: 2016-09-20
Enrollment: 160
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Cumulative incidence of atopic dermatitis
timeFrame: 12 months
Secondary outcomes:
measure: Cumulative incidence of atopic dermatitis
timeFrame: 24 months
measure: AD incidence density
timeFrame: 12 months
measure: AD incidence density
timeFrame: 24 months
measure: Eczema Area and Severity Index (EASI)
timeFrame: 12 months
measure: Eczema Area and Severity Index (EASI)
timeFrame: 24 months
measure: Infant Dermatitis Quality of Life (IDQoL)
timeFrame: 12 months
measure: Infant Dermatitis Quality of Life (IDQoL)
timeFrame: 24 months
measure: Transepidermal water loss (TEWL) on the midvolar forearm
timeFrame: at ages of 14 days, 1, 3, 6, 12 months and 2 years
measure: Skin surface pH on the midvolar forearm
timeFrame: at ages of 14 days, 1, 3, 6, 12 months and 2 years
measure: Stratum Corneum Hydration (SCH) on the forearm
timeFrame: at ages of 14 days, 1, 3, 6, 12 months and 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite Universitätsmedizin Berlin
name: Ulrike Blume-Peytavi, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.