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| ID | Type | Description | Link |
|---|---|---|---|
| CCER 08-09-009 | Other Identifier | Comité centrale d'éthique de la recherche |
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Patients would improve naturally due to weather conditions
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| Name | Class |
|---|---|
| Innovaderm Research Inc. | OTHER |
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Atopic dermatitis is one of the most frequent skin diseases. The disease is often worst during winter months when the skin is drier. Mild to moderate cases of atopic dermatitis are often controlled by a moisturizer alone. The use of moisturizers has been shown to have beneficial effects on atopic dermatitis. It can break the dry skin cycle by hydrating the upper layer of the skin which may prevent the recurrence of the disease and can reduce the use of cream or ointment medications such as corticosteroids. Formulation 609580 20 was developed to keep the moisturizing efficacy of formulation 609209 but to improve its tolerance and cosmetic acceptability (easier to apply, nicer texture, etc.). The new formulation contains the same quantity of shea butter and glycerin but in a different excipient (inactive substance) than the commercial product. In addition, vitamin B3 was added to see if it could help in reducing itching.
The purpose of this study is to determine the safety and efficacy of two study products in children with atopic dermatitis. One of the study products (formulation 609580 20) is not commercially available (outside of clinical trials such as this one). The other study product (formulation 609209) has been approved in Canada and is currently available commercially under the trade name Lipikar Baume.
For this study the child will be randomly assigned to one of the following two groups:
A randomized clinical trial performed at five (5) centers (Montreal, Laval, Quebec City, (Quebec); Markham, London (Ontario), Canada). One hundred (100) patients are enrolled in the study. Subjects and parent(s) or guardian are asked to present to the clinic for five (5) visits (Screening, D0, D7, D42, D56). Formulation 609580 20 or 609209 is applied twice a day (morning and evening) to the whole body for a total of 42 days and then there is a crossover between the two formulations.
Efficacy is evaluated at D0, D7 and D42 measured by SCORAD (scoring atopic dermatitis). Tolerance is evaluated by the investigator at D7, D42 and D56. Global efficacy is measured by parents and investigator at D7 and D42. Medical photographs (optional) of lesions are taken with patients consent at D0 and D42. A crossover between the two products occurs at day 42 so that cosmetic acceptability can be compared at D42 and D56. Skin examinations are performed at all visits. A quality of life questionnaire is filled out by the parent(s) at D0 and D42.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 609580 20 then 609209 | Experimental | 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 then 609580 20 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation 609580 20 | Other | Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | 7 , 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 investigator).
| 7, 42 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD | Innovaderm Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Guenther Dermatology Research Center | London | Ontario | Canada | |||
| Lynderm Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Formulation 609580 20 Then 609209 | 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. |
| FG001 | Formulation 609209 Then 609580 20 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention - 42 Days |
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| |||||||||||||||||||||
| After Crossover - 14 Days (up to Day 56) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Formulation 609580 20 Then 609209 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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. | All subjects that had at least one evaluation after the Day 0 visit were included in the efficacy evaluations if their overall compliance was between 70 and 120%. Missing data were replaced using the last observation carried forward (LOCF) method. Two patients lost to follow-up and 5 less than 70% compliant were not included in this analysis. | Posted | Mean | Standard Deviation | Percentage of change in SCORAD | 7 , 42 days |
|
56 days between the date of the first application and the final date of the study regardless of their compliance or their completion of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formulation 609580 20 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annie Levesque | Innovaderm Research | 514-521-4285 | 222 | alevesque@innovaderm.ca |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Formulation 609209 (Lipikar Baume) | Other | Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing. |
|
|
| Change in Mean Global Efficacy (by Parent) | 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).
| 7, 42 days |
| Change in Mean Quality of Life | 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). | 0, 42 days |
| 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 first 42 prior to the crossover. Scale from 44 (worst) to -44 (best). | 0, 42 days |
| Change in Mean Cosmetic Acceptability After 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. | 14 days (Day 42 to Day 56 of the study) |
| Change in Tolerance Before Crossover | Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale:
| 7, 42 days |
| Change in Mean Tolerance After Crossover | Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study):
| 14 Days (Day 42 to Day 56 of the study) |
| Preferred Formulation | 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. | 56 days |
| Markham |
| Ontario |
| Canada |
| Innovaderm Research Inc | Laval | Quebec | Canada |
| Innovaderm Research Inc | Montreal | Quebec | Canada |
| Centre de recherche dermatologique du Québec Métropolitain | Québec | Quebec | Canada |
| NOT COMPLETED |
|
|
| Formulation 609209 Then 609580 20 |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| SCORAD - Score Atopic Dermatitis | 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:
| Mean | Standard Deviation | Units on a scale |
|
| Quality of Life Questionnaire | 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). | Mean | Standard Deviation | Units on a scale |
|
| OG000 | Formulation 609580 20 | 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. |
| OG001 | Formulation 609209 | 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. |
|
|
| Secondary | 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 investigator).
| All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, one missing Day 7 value and 5 less than 70% compliant were not included in this analysis. | Posted | Apr 2010 | Mean | Standard Deviation | Units on a scale | 7, 42 Days |
|
|
|
| Secondary | Change in Mean Global Efficacy (by Parent) | 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).
| All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, two missing Day 7 value and 5 less than 70% compliant were not included in this analysis. | Posted | Apr 2010 | Mean | Standard Deviation | Units on a scale | 7, 42 days |
|
|
|
| Secondary | Change in Mean Quality of Life | 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). | All subjects with at least one evaluation after the Day 0 visit were included in this evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0, 42 days |
|
|
|
| Secondary | 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 first 42 prior to the crossover. Scale from 44 (worst) to -44 (best). | All subjects with at least one evaluation after the Day 0 visit were included in the cosmetic evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0, 42 days |
|
|
|
| Secondary | Change in Mean Cosmetic Acceptability After 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. | Subjects that had at least one evaluation after the Day 0 visit were in analysis if they had overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward. Two patients lost to follow-up, 1 early term and 5 less than 70% compliant were not included in this analysis and participants swapped after crossover. | Posted | Mean | Standard Deviation | Units on a scale | 14 days (Day 42 to Day 56 of the study) |
|
|
|
| Secondary | Change in Tolerance Before Crossover | Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale:
| All subjects that had at least one evaluation after the Day 7 (no Day 0 visit for this parameter) visit were included in the efficacy evaluations. Missing data were replaced using the last observation carried forward (LOCF) method. Four patients had no Day 7 visit to carry forward and were not included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 7, 42 days |
|
|
|
| Secondary | Change in Mean Tolerance After Crossover | Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study):
| All subjects that had at least one evaluation after Day 7 (no day 0 visit for this parameter) were included in the analysis. Missing data were replaced using the last observation carried forward method. The same patients as in outcome #7 did not have results to carry forward and were not included in analysis (subjects swapped after crossover). | Posted | Mean | Standard Deviation | Units on a scale | 14 Days (Day 42 to Day 56 of the study) |
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|
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| Secondary | Preferred Formulation | 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 subjects with an evaluation after the Day 42 visit were included in this evaluation if their overall compliance was between 70 and 120%. Two patients lost to follow-up, one with no Day 56 value and 5 less than 70% compliant were not included in this analysis. | Posted | Number | Participants | 56 days |
|
|
|
| 0 |
| 73 |
| 8 |
| 73 |
| EG001 | Formulation 609209 | 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. | 0 | 73 | 12 | 73 |
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|