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

Not Applicable

Terminated

Conditions: Atopic Dermatitis
Eczema
Asthma
Food Allergies
Allergic Rhinitis

Interventions: Drug: Lipikar Balm AP

Registration Number: NCT01577628

Lead Sponsor: Cosmetique Active International

Brief 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).

Detailed 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).

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 2

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Lipikar Balm AP	Lipikar Balm AP	Daily application of Lipikar Balm AP starting at birth

Primary Outcome Measures

Name	Time	Method
Proportion of Infants Who Develop Atopic Dermatitis	2 years	Proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group

Secondary Outcome Measures

Name	Time	Method
Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Atopic Dermatitis	2 years	Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Proportion of Infants Who Develop a Food Allergy	2 years	Proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop a Food Allergy	2 years	Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Time of Onset of Food Allergy in Infants	2 years	Time of onset of food allergy in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Time of Onset of Atopic Dermatitis	2 years	Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Asthma	2 years	Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Proportion of Infants Who Develop Asthma	2 years	Proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Time of Onset of Asthma in Infants	2 years	Time of onset of asthma in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Adverse Events (AEs) Collection	2 years	Adverse events (Skin AEs, asthma, food allergies, allergic rhinitis and any AE related to Lipikar Syndet, Lipikar Balm AP (group 1) or any other moisturizer application (group 2) will be collected.

Trial Locations

Locations (4): Windsor Clinical Research
🇨🇦
Windsor, Ontario, Canada
Hamzavi Dermatology/Dermatology Specialists of Canton
🇺🇸
Canton, Michigan, United States
Hamzavi Dermatology
🇺🇸
Fort Gratiot, Michigan, United States
Lynderm Research
🇨🇦
Markham, Ontario, Canada