Back to resultsTolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Formulation 609580 20
Formulation 609209 (Lipikar Baume)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Vitamin B3
Eligibility Criteria
Inclusion Criteria:
- 3-12 years of age
- Suffering from a mild to moderate atopic dermatitis that is amenable to treatment with moisturizer only
- SCORAD (scoring atopic dermatitis) of 10-30 at screening and Day 0
- Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features; please refer to appendix D)
- Atopic dermatitis has been, in the opinion of the investigator, stable for the past 28 days
- Subject with parents able to apply the study product twice a day (each morning and evening) for a 56 days period
- Subject with parents agreeing not to change their child's lifestyle during the study period (including their usual body hygiene product (soap), the number of baths and showers per day, the laundry detergent and fabric softener used to wash the child's clothes)
- Subject with parents agreeing that their child uses only the test product as body emollient on the whole body during the study period
- Subject with parents available to completely follow the study with their child
- Subject with parents able and willing to sign the informed consent form and to comply with the study regulations of this protocol
Exclusion Criteria:
- Subject has another dermatological condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
- Subject has a previous history of allergy to cosmetic products or any ingredients of the tested formulations
- Subject has received any systemic treatment, including PUVA (psoralen ultraviolet A) therapy for atopic dermatitis within 28 days prior to screening
- Subject has received any topical immunomodulators for atopic dermatitis (such as pimecrolimus or tacrolimus) within 14 days of Day 0
- Subject has received phototherapy within 14 days of Day 0
- Subject intends to expose him/herself to the sun during the trial
- Subject has known allergy to any component of tested products
- Subject has used any experimental treatment within 14 days of Day 0
- Subject has used any topical corticosteroid of class I-IV within 14 days of Day 0
Sites / Locations
- The Guenther Dermatology Research Center
- Lynderm Research
- Innovaderm Research Inc
- Innovaderm Research Inc
- Centre de recherche dermatologique du Québec Métropolitain
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Formulation 609580 20 then 609209
Formulation 609209 then 609580 20
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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 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 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).
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).
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.
Change in Tolerance Before 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 Mean Tolerance After 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
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.
Full Information
NCT ID
NCT00931411
First Posted
June 29, 2009
Last Updated
September 18, 2011
Sponsor
Cosmetique Active International
Collaborators
Innovaderm Research Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00931411
Brief Title
Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Terminated
Why Stopped
Patients would improve naturally due to weather conditions
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cosmetique Active International
Collaborators
Innovaderm Research Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
Group 1: 50 children will receive formulation 609209, the commercial formula for 42 days and will receive formulation 609580 20, the new formula, for 14 days.
Group 2: 50 children will receive formulation 609580 20, the new formula, for 42 days and will receive formulation 609209, the commercial formula, for 14 days.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Vitamin B3
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Formulation 609580 20 then 609209
Arm Type
Experimental
Arm Description
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.
Arm Title
Formulation 609209 then 609580 20
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Formulation 609580 20
Intervention Description
Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
Intervention Type
Other
Intervention Name(s)
Formulation 609209 (Lipikar Baume)
Other Intervention Name(s)
Lipikar Baume
Intervention Description
Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
Primary Outcome Measure Information:
Title
Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0
Description
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.
Time Frame
7 , 42 days
Secondary Outcome Measure Information:
Title
Change in Mean Global Efficacy (by Investigator).
Description
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
Time Frame
7, 42 Days
Title
Change in Mean Global Efficacy (by Parent)
Description
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
Time Frame
7, 42 days
Title
Change in Mean Quality of Life
Description
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).
Time Frame
0, 42 days
Title
Change in Mean Cosmetic Acceptability Before Crossover
Description
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).
Time Frame
0, 42 days
Title
Change in Mean Cosmetic Acceptability After Crossover
Description
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.
Time Frame
14 days (Day 42 to Day 56 of the study)
Title
Change in Tolerance Before Crossover
Description
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
Time Frame
7, 42 days
Title
Change in Mean Tolerance After Crossover
Description
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
Time Frame
14 Days (Day 42 to Day 56 of the study)
Title
Preferred Formulation
Description
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.
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
3-12 years of age
Suffering from a mild to moderate atopic dermatitis that is amenable to treatment with moisturizer only
SCORAD (scoring atopic dermatitis) of 10-30 at screening and Day 0
Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features; please refer to appendix D)
Atopic dermatitis has been, in the opinion of the investigator, stable for the past 28 days
Subject with parents able to apply the study product twice a day (each morning and evening) for a 56 days period
Subject with parents agreeing not to change their child's lifestyle during the study period (including their usual body hygiene product (soap), the number of baths and showers per day, the laundry detergent and fabric softener used to wash the child's clothes)
Subject with parents agreeing that their child uses only the test product as body emollient on the whole body during the study period
Subject with parents available to completely follow the study with their child
Subject with parents able and willing to sign the informed consent form and to comply with the study regulations of this protocol
Exclusion Criteria:
Subject has another dermatological condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
Subject has a previous history of allergy to cosmetic products or any ingredients of the tested formulations
Subject has received any systemic treatment, including PUVA (psoralen ultraviolet A) therapy for atopic dermatitis within 28 days prior to screening
Subject has received any topical immunomodulators for atopic dermatitis (such as pimecrolimus or tacrolimus) within 14 days of Day 0
Subject has received phototherapy within 14 days of Day 0
Subject intends to expose him/herself to the sun during the trial
Subject has known allergy to any component of tested products
Subject has used any experimental treatment within 14 days of Day 0
Subject has used any topical corticosteroid of class I-IV within 14 days of Day 0
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD
Organizational Affiliation
Innovaderm Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Guenther Dermatology Research Center
City
London
State/Province
Ontario
Country
Canada
Facility Name
Lynderm Research
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Innovaderm Research Inc
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Innovaderm Research Inc
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre de recherche dermatologique du Québec Métropolitain
City
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis
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