Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis

Asthma Clinical Trial

Official title: Randomized, Multicentric, Controlled Study on the Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis

Status Terminated

Clinical Trial 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).

Clinical Trial Description

To be eligible, pregnant women must be at least 16 weeks pregnant. Expecting mothers (or the father of the infant to be born) or related sibling of the child to be born must meet or previously have met criteria for atopic dermatitis. In addition, one of the parents or sibling of the child to be born must suffer from allergic rhinitis or asthma.

Pregnant women will be randomized at screening and their infant will be seen at 1 month, 6 months, 12 months (1 year) and 24 months (2 years) after birth.

Women randomized to group 1 will be requested to use the same body cleanser (Lipikar Syndet) and to apply Lipikar Balm AP to their child once daily immediately after bathing on a well blotted skin (within 3 minutes of bathing) to the entire body (including the face) from birth, while women randomized to group 2 will be in a non-interventional control group.

The presence of atopic dermatitis (using Hanifin's criteria(1)) and study products use will be assessed at 1 month, 6 months, 12 months and 24 months after birth. A buccal smear will be sampled from all infants at 1 month after birth for the genotyping of filaggrin (FLG) gene.

In addition, adverse events evaluation and parent questioning on infants development of food allergies and asthma will be performed at 1 month, 3 months (telephone visit), 6 months, 12 months and 24 months after birth. Infants will be followed for a total of two years after birth.

Lipikar Balm AP is a commonly used cosmetic moisturizer commercially available in many countries including Canada. This moisturizer is recommended for extreme dryness and atopy-prone skin in babies, children and adults. It contains shea butter, paraffin, waxes and vegetable oils. The high content in shea butter and the fraction chosen showed a greater expression of constitutive ceramids forming the barrier function of the skin (data on file at La Roche-Posay). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Food Allergies
• Food Hypersensitivity

• NCT number: NCT01577628
• Study type: Interventional
• Source: Cosmetique Active International
• Status: Terminated
• Phase: N/A
• Start date: June 2012
• Completion date: February 2013