Clinical Trial: Atopic Dermatitis in Atopy Predisposed Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 P

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 Summary:

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.


Sponsor: HiPP GmbH & Co.

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cumulative incidence of atopic dermatitis [ Time Frame: 24 months ]
  • AD incidence density [ Time Frame: 12 months ]
  • AD incidence density [ Time Frame: 24 months ]
  • Eczema Area and Severity Index (EASI) [ Time Frame: 12 months ]
  • Eczema Area and Severity Index (EASI) [ Time Frame: 24 months ]
  • Infant Dermatitis Quality of Life (IDQoL) [ Time Frame: 12 months ]
  • Infant Dermatitis Quality of Life (IDQoL) [ Time Frame: 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 ]
  • Skin surface pH on the midvolar forearm [ Time Frame: 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 ]


Original Secondary Outcome: Same as current

Information By: HiPP GmbH & Co.

Dates:
Date Received: September 15, 2016
Date Started: October 2016
Date Completion: December 2020
Last Updated: December 9, 2016
Last Verified: December 2016