Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis
| Status: | Terminated |
|---|---|
| Conditions: | Allergy, Asthma, Psoriasis, Skin and Soft Tissue Infections, Neurology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Neurology, Otolaryngology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2012 |
| End Date: | February 2013 |
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).
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).
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).
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).
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
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