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: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cosmetique Active International
• Collaborator: Innovaderm Research Inc.

Criteria

Inclusion Criteria:

• Women 18 years of age or older at the time of consent

• At least 16 weeks pregnant

• Women with a high risk of having a child with atopic dermatitis defined as having one parent or related sibling of the child to be born who currently (or previously) suffers from atopic dermatitis and who also suffers from asthma or allergic rhinitis

• Be willing to use the body cleanser Lipikar Syndet and to apply Lipikar Balm AP (if randomized to group 1) every day from birth for 2 years

• Capable of giving informed consent and the consent must be obtained prior to any study related procedures

Exclusion Criteria:

• Preterm birth defined as birth before 37 weeks of gestation

• Major congenital anomaly at birth

• Presence of significant dermatitis at birth

• Any medical problem at birth that would prevent the daily use of Lipikar Syndet and/or Lipikar Balm AP (regardless of the group the subject was randomized to) or would prevent evaluation of the skin for the presence of atopic dermatitis