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

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

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).

Study Overview

• Status: Terminated
• Conditions: Asthma; Allergic Rhinitis; Eczema; Atopic Dermatitis; Food Allergies
• Intervention / Treatment: Drug: Lipikar Balm AP

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).

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada, L3P 1A8
      • Lynderm Research
    • Windsor, Ontario, Canada, N8W 5L7
      • Windsor Clinical Research
• United States
  • Michigan
    • Canton, Michigan, United States, 48187
      • Hamzavi Dermatology/Dermatology Specialists of Canton
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Group 1: Lipikar Balm AP; Daily application of Lipikar Balm AP starting at birth	Drug: Lipikar Balm AP; Daily application of Lipikar Balm AP starting at birth
NO_INTERVENTION: Group 2: No intervention control group; Subjects may use a moisturizer if they wish to but no instruction or product is provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Infants Who Develop Atopic Dermatitis	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Infants Who Develop Asthma	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	2 years
Proportion of Infants Who Develop a Food Allergy	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	2 years
Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Atopic Dermatitis	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	2 years
Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Asthma	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	2 years
Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop a Food Allergy	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	2 years
Time of Onset of Asthma in Infants	Time of onset of asthma in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group	2 years
Time of Onset of Food Allergy in Infants	Time of onset of food allergy in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group	2 years
Adverse Events (AEs) Collection	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.	2 years
Time of Onset of Atopic Dermatitis	Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group	2 years

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Collaborators: Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (ESTIMATE): April 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 21, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; Prevention; Infant; Eczema; Allergic rhinitis; Dermatitis; Emollient; Food allergy; Skin diseases; Moisturizer; Skin barrier
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Skin Diseases, Genetic; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Skin Diseases, Eczematous; Dermatitis; Rhinitis; Rhinitis, Allergic; Eczema; Dermatitis, Atopic; Food Hypersensitivity
• Other Study ID Numbers: LRP11005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO