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Atopic DermatitisNCT01577628

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

A study testing Lipikar Balm AP in people with Atopic Dermatitis and Eczema, run by Cosmetique Active International at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis, Eczema, Asthma
What is being tested?
Lipikar Balm AP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
4 sitesin 2 countries
Study dates
Jun 2012to Feb 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States2 sites

  • Hamzavi Dermatology/Dermatology Specialists of Canton

    Canton, Michigan, 48187

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059

Other trials in United States

Canada2 sites

  • Lynderm Research

    Markham, Ontario, L3P 1A8

  • Windsor Clinical Research

    Windsor, Ontario, N8W 5L7

Other trials in Canada

About this study

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

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.

Read more

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).

Read the 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).

Being tested
Lipikar Balm AP
Keywords
Dermatitis, Eczema, Skin diseases, Skin barrier, Prevention, Infant, Moisturizer, Emollient, Asthma, Food allergy, Allergic rhinitis
Medical subject headings
Dermatitis, Atopic, Eczema, Asthma, Food Hypersensitivity, Rhinitis, Allergic, Dermatitis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lipikar Balm APDrug

    Daily application of Lipikar Balm AP starting at birth

Study groups in NCT01577628
Study groupRoleWhat they receive
Group 1: Lipikar Balm APOtherDaily application of Lipikar Balm AP starting at birth
Receives: Drug: Lipikar Balm AP
Group 2: No intervention control groupNo interventionSubjects may use a moisturizer if they wish to but no instruction or product is provided

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (9)

  1. 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

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. 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

    Measured: 2 years

  4. 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

    Measured: 2 years

  5. 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

    Measured: 2 years

  6. 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

    Measured: 2 years

  7. 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

    Measured: 2 years

  8. 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.

    Measured: 2 years

  9. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01577628
Sponsor's protocol ID
LRP11005
Status last verified
Mar 2016
First submitted
10 Apr 2012
Last updated
21 Apr 2016
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lipikar Balm AP in people with Atopic Dermatitis and Eczema, run by Cosmetique Active International at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Infants Who Develop Atopic Dermatitis (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01577628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.

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