Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis
Status:
Terminated
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
There is a lack of prospective scientific data on the regular use of moisturizers in patients
at risk of developing atopic dermatitis. Although generally accepted and widely used for
secondary prevention, emollients have not been studied as a primary prevention strategy.
Strategies previously studied for the prevention of atopic dermatitis include maternal and
child's dietary manipulations, allergens avoidance, delay of food introduction, exclusive
breastfeeding and probiotic supplementation. Despite years of research, none of those
strategies yielded to strong evidence of a protective effect. There is therefore a need to
explore novel strategies.
There is a need to compare the cumulative incidence rate of atopic dermatitis in newborns
using a standard bathing and moisturizing routine with a good moisturizer to a non
interventional group.
This 2-year study will recruit approximately four hundred and sixty (460) pregnant women with
a first degree relative of the child to be born who currently has (or previously had) a
diagnosis of atopic dermatitis in order to study approximately 200 eligible newborns in each
of the two study groups at the beginning of the study.
Pregnant women will be randomized (1:1) to either daily use of the moisturizer Lipikar Balm
AP (applied to their infant) starting from birth (Group 1) immediately after bathing or to no
intervention (Group 2).