Atopic Dermatitis in Atopy Predisposed Infants

NCT02906475 | Completed

• 1 other identifier: 508276
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of atopic dermatitis

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

  12 months

Secondary Outcomes (10)

• Cumulative incidence of atopic dermatitis

  24 months

• AD incidence density

  12 months

• AD incidence density

  24 months

• Eczema Area and Severity Index (EASI)

  12 months

• Eczema Area and Severity Index (EASI)

  24 months

Study Arms (2)

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.

Other: standardized skin care regimen

Control

NO INTERVENTION

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

Interventions

standardized skin care regimen OTHER

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

Intervention: standardized skin care regimen

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HiPP GmbH & Co. Vertrieb KG: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Charite Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 22424882 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ulrike Blume-Peytavi, Prof. Dr.

  Charite Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 20, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)