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

This study has been terminated.
(Sponsor Decision)
Sponsor:
Collaborator:
Innovaderm Research Inc.
Information provided by (Responsible Party):
Robert BISSONNETTE, Cosmetique Active International
ClinicalTrials.gov Identifier:
NCT01577628
First received: April 10, 2012
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention
Atopic Dermatitis
Eczema
Asthma
Food Allergies
Allergic Rhinitis
Drug: Lipikar Balm AP

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

Resource links provided by NLM:


Further study details as provided by Cosmetique Active International:

Primary Outcome Measures:
  • Proportion of infants who develop atopic dermatitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Proportion of infants who develop asthma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 a food allergy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 atopic dermatitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop asthma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop a food allergy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 asthma in infants [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time of onset of asthma in 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time of onset of food allergy in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group

  • Adverse events (AEs) collection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Time of onset of atopic dermatitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group


Enrollment: 2
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577628

Locations
United States, Michigan
Hamzavi Dermatology/Dermatology Specialists of Canton
Canton, Michigan, United States, 48187
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Canada, Ontario
Lynderm Research
Markham, Ontario, Canada, L3P 1A8
Windsor Clinical Research
Windsor, Ontario, Canada, N8W 5L7
Sponsors and Collaborators
Cosmetique Active International
Innovaderm Research Inc.
Investigators
Principal Investigator: Robert Bissonnette, MD, FRCPC Innovaderm Research
  More Information

No publications provided

Responsible Party: Robert BISSONNETTE, President and Dematologist, Cosmetique Active International
ClinicalTrials.gov Identifier: NCT01577628     History of Changes
Other Study ID Numbers: LRP11005
Study First Received: April 10, 2012
Last Updated: February 26, 2013
Health Authority: Canada: Health Canada

Keywords provided by Cosmetique Active International:
Dermatitis
Eczema
Skin diseases
Skin barrier
Prevention
Infant
Moisturizer
Emollient
Asthma
Food allergy
Allergic rhinitis

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Dermatitis
Dermatitis, Atopic
Eczema
Food Hypersensitivity
Rhinitis
Rhinitis, Allergic, Perennial
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 18, 2014