Daily application of Lipikar Balm AP starting at birth

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

Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth

Group 1: Lipikar Balm AP

Group 2: No Intervention Control Group

Total

Sex: Female, Male

Region of Enrollment

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

Proportion of Infants Who Develop Atopic Dermatitis

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 Asthma

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

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 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 Atopic Dermatitis

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 Asthma

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

Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop a Food Allergy

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 Asthma 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

Time of Onset of Food Allergy in Infants

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.

Adverse Events (AEs) Collection

Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group

Time of Onset of Atopic Dermatitis

Subject was not randomized to either treatment prior to study termination.

Screen Only

Overall Study

Dr Robert Bissonnette

Atopic Dermatitis

Eczema

Asthma

Food Allergies

Allergic Rhinitis

Lipikar Balm AP

Hamzavi Dermatology/Dermatology Specialists of Canton

Hamzavi Dermatology

Lynderm Research

Windsor Clinical Research

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

Robert BISSONNETTE

President and Dematologist

Cosmetique Active International

Innovaderm Research Inc.

Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.

Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.

Formulation 609580 20 Then 609209

Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.

Formulation 609209 Then 609580 20

SCORAD - Score Atopic Dermatis measures intensity of erythema/darkening, edema/papulation, oosing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst score is 103.
Example:
18 * 3.5 = 63
63 + 20 = 83
83 + 10 + 10 = 103

SCORAD - Score Atopic Dermatitis

The effect of formulation 609580 20 to improve quality of life compared to formulation 609209 as measured by changes in the quality of life questionnaire score from Day 0 to Day 42. Scale from -46 (worse) to 46 (better).

Quality of Life Questionnaire

The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103.

Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.

Formulation 609580 20

Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.

Formulation 609209

Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0

The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by investigator).
0 = worsening
1 = No change
2 = Mild Improvement
3 = Moderate Improvement
4 = Good Improvement
5 = Excellent Improvement

Change in Mean Global Efficacy (by Investigator).

The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by parent).
0 = worsening
1 = No change
2 = Mild Improvement
3 = Moderate Improvement
4 = Good Improvement
5 = Excellent Improvement

Change in Mean Global Efficacy (by Parent)

The effect of formulation 609580 20 to improve quality of life compared to formulation 609209 as measured by changes in the quality of life questionnaire score from Day 0 to Day 42. Scale from -46 (worst) to 46 (best).

Change in Mean Quality of Life

The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the first 42 prior to the crossover. Scale from 44 (worst) to -44 (best).

Change in Mean Cosmetic Acceptability Before Crossover

The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the 2 week period after the crossover. Scale from 44 (worst) to -44 (best). The 14 Days after the crossover is the same as Day 56 in the study.

Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.

Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.

Change in Mean Cosmetic Acceptability After Crossover

Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale:
1) Very good tolerance: no objective or subjective intolerance during the study
2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign
3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign
4) Poor tolerance: symptoms requiring cessation of application, no objective sign
5) Very poor tolerance: objective signs of irritative or allergic dermatitis

Change in Tolerance Before Crossover

Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study):
1) Very good tolerance: no objective or subjective intolerance during the study
2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign
3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign
4) Poor tolerance: symptoms requiring cessation of application, no objective sign
5) Very poor tolerance: objective signs of irritative or allergic dermatitis

Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.

Change in Mean Tolerance After Crossover

Number of participants that preferred one formulation over the other. All patients started the study with one cream and crossed over to the other cream at Day 42 for another 14 days. Participants were asked which they prefered.

All Study Patients

Preferred Formulation

First Intervention - 42 Days

After Crossover - 14 Days (up to Day 56)

Annie Levesque

Adverse events that were recorded before Day 42 for the group "Formulation 609580 20 then 609209" and recorded in the subsequent 2 weeks for the group "Formulation 609209 then 609580 20". Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups.

Adverse events that were recorded before Day 42 for the group "Formulation 609209 then 609580 20" and recorded in the subsequent 2 weeks for the group "Formulation 609580 20 then 609209". Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups.

Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.

Formulation 609209 (Lipikar Baume)

The Guenther Dermatology Research Center

Innovaderm Research Inc

Centre de recherche dermatologique du Québec Métropolitain

Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis

Double-Blind Study of Tolerance and Moisturizers Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis Under Normal Conditions of Use

vitellaria paradoxa/kosmētika

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

Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis

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