Atopic DermatitisNCT00931411
Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis
A study testing Formulation 609580 20 and Formulation 609209 (Lipikar Baume) in people with Atopic Dermatitis, run by Cosmetique Active International at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Formulation 609580 20 and Formulation 609209 (Lipikar Baume)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2009to Jul 2009
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Innovaderm Research Inc
Laval, Quebec
The Guenther Dermatology Research Center
London, Ontario
Lynderm Research
Markham, Ontario
Innovaderm Research Inc
Montreal, Quebec
Centre de recherche dermatologique du Québec Métropolitain
Québec, Quebec
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Formulation 609580 20, Formulation 609209 (Lipikar Baume)
- Keywords
- Atopic Dermatitis, Vitamin B3
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation 609580 20Other
Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
Formulation 609209 (Lipikar Baume)Other
Also called Lipikar Baume
Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Formulation 609580 20; Other: Formulation 609209 (Lipikar Baume) |
| 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. Receives: Other: Formulation 609580 20; Other: Formulation 609209 (Lipikar Baume) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 , 42 days
Secondary outcomes (8)
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
Measured: 7, 42 Days
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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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:
- 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
Measured: 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):
- 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
Measured: 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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJul 2009
Why it stopped: Patients would improve naturally due to weather conditions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Responsible party
- Principal investigator, Robert BISSONNETTE, Cosmetique Active International
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931411
- Sponsor's protocol ID
- LRP07019
- Other IDs
- CCER 08-09-009
- Status last verified
- Sep 2011
- First submitted
- 29 Jun 2009
- Last updated
- 20 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00931411
- Acronym / sponsor ID
- LRP07019
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Vitamin B3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients would improve naturally due to weather conditions
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 3 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation 609580 20 then 609209 | Experimental | Other: Formulation 609580 20, Other: Formulation 609209 (Lipikar Baume)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 | Other: Formulation 609580 20, Other: Formulation 609209 (Lipikar Baume)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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formulation 609580 20Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing. | Other | Formulation 609209 then 609580 20, Formulation 609580 20 then 609209 |
| Formulation 609209 (Lipikar Baume)Also: Lipikar BaumeMoisturizer, applied topically to whole body, twice a day, morning and evening, after bathing. | Other | Formulation 609209 then 609580 20, Formulation 609580 20 then 609209 |
Primary outcome
Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0
Time frame: 7 , 42 days
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.
8 secondary outcomes
Change in Mean Global Efficacy (by Investigator).
Time frame: 7, 42 Days
Change in Mean Global Efficacy (by Parent)
Time frame: 7, 42 days
Change in Mean Quality of Life
Time frame: 0, 42 days
Change in Mean Cosmetic Acceptability Before Crossover
Time frame: 0, 42 days
Change in Mean Cosmetic Acceptability After Crossover
Time frame: 14 days (Day 42 to Day 56 of the study)
Change in Tolerance Before Crossover
Time frame: 7, 42 days
Change in Mean Tolerance After Crossover
Time frame: 14 Days (Day 42 to Day 56 of the study)
Preferred Formulation
Time frame: 56 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD principal investigator
Innovaderm Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formulation 609580 20 and Formulation 609209 (Lipikar Baume) in people with Atopic Dermatitis, run by Cosmetique Active International at 5 sites in Canada.
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 10 inclusion and 9 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 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in 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 3 Feb 2011). 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?
Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0 (time frame: 7 , 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2011.