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

NCT01577628 | Terminated Results

• 1 other identifier: LRP11005
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 4

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).

Conditions

Atopic Dermatitis; Eczema; Asthma; Food Allergies; Allergic Rhinitis

Keywords

Dermatitis; Eczema; Skin diseases; Skin barrier; Prevention; Infant; Moisturizer; Emollient; Asthma; Food allergy; Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Proportion of Infants Who Develop Asthma

  2 years

• 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 Atopic Dermatitis

  2 years

• 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 a Food Allergy

  2 years

Study Arms (2)

Group 1: Lipikar Balm AP

OTHER

Daily application of Lipikar Balm AP starting at birth

Drug: Lipikar Balm AP

Group 2: No intervention control group

NO INTERVENTION

Subjects may use a moisturizer if they wish to but no instruction or product is provided

Interventions

Lipikar Balm AP DRUG

Daily application of Lipikar Balm AP starting at birth

Group 1: Lipikar Balm AP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cosmetique Active International: lead
• Innovaderm Research Inc.: collaborator

Study Sites (4)

Hamzavi Dermatology/Dermatology Specialists of Canton

Canton, Michigan, 48187, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Lynderm Research

Markham, Ontario, L3P 1A8, Canada

Location

Windsor Clinical Research

Windsor, Ontario, N8W 5L7, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Asthma; Food Hypersensitivity; Rhinitis, Allergic; Dermatitis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr Robert Bissonnette
• Organization: Innovaderm Research

rbissonnette@innovaderm.ca

514-521-4285

Study Officials

• Robert Bissonnette, MD, FRCPC

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and Dematologist

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 16, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 21, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (2)