Atopic DermatitisNCT05644691
Impact of the Daily Use of Emollient on Corticosteroids Consumption in Patients With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Cosmetique Active International at 1 site in Slovakia.
Trial summary
This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lipikar Baume AP+M and Usual emollient
- How many people
- 119 participants
- Where
- 1 siteSlovakia
- Study dates
- 14 Oct 2020to 14 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients meeting the inclusion and exclusion criteria and agreeing to participate in the study
Who may be able to join
- diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features)
- mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion between 20 and 30)
- able to apply the emollient (each morning and evening) during a three-month period
Who cannot join
- presenting with another dermatological condition that could interfere with clinical evaluation
- having received any systemic treatment, including PUVAtherapy for atopic dermatitis in the month prior to Day 0
- who intend to expose themselves to the sun during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Daily Use of the Tested Emollient on Corticosteroids Consumption in Patients Minimum 3 Years Old With Atopic Dermatitis (SCORAD 20-30) Versus Their Usual Emollient
This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.
Read the detailed description
The study is conducted in compliance, as closely as possible, with the current version of the world medical association declaration of Helsinki, local regulations based on International Council on Harmonisation (ICH) guidelines for Good Clinical Practice.
The primary objective of this study is to compare the tested emollient and the usual emollient through the weight of used dermocorticosteroid. The weight of used dermocorticosteroid is compared at the end of the study by a Student t-test (or a non parametric Wilcoxon test depending on the data distribution).
The following hypotheses are used for the estimation of the sample size calculation:
- Power (1 - β) = 80%
- Two-sided significance level (α) = 5%
- Expected inter-group difference = 0.6g
- Standard deviation = 1.4g.
Statistical analyses is performed with SAS® version 9.4 or higher (SAS institute, North Carolina, USA).
Continuous variables are summarized as number of observations, mean, standard deviation, standard error, median, minimum and maximum (95% confidence interval will be provided if necessary). For categorical variables, subject counts and percentages will be provided.
Analyses use 2-sided tests at the 5% significance level, except the normality tested at the threshold of 1% (Shapiro-Wilk test).
- Conditions
- Atopic Dermatitis
- Being tested
- Lipikar Baume AP+M, Usual emollient
- Keywords
- atopic dermatitis, corticosteroids, SCORAD
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipikar Baume AP+MOther
application of Lipikar Baume AP+M twice daily for 3 months in parallel with the corticosteroid treatment
Usual emollientOther
application of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment
| Study group | Role | What they receive |
|---|---|---|
| Lipikar Baume AP+M | The group applies Lipikar Baume AP+M twice daily for 3 months. Participants have 4 visits (Day0, Day 28, Day56, Day84) with different outcome measures including self-evaluations). Receives: Other: Lipikar Baume AP+M | |
| Usual emollient | The group applies their usual emollient twice daily for 3 months. Participants have 4 visits (Day0, Day28, Day56, Day84 with different outcome measures including self-evaluations). Receives: Other: Usual emollient |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of treatments
the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications)
Measured: from baseline to Day84
Secondary outcomes (9)
change in SCORing Atopic Dermatitis (SCORAD) measure
evaluation of SCORAD by the dermatologist in relation with the emollient consumption (weight of product and number of applications)
Measured: from baseline to Day84
change in Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) measure
evaluation of PO-SCORAD by the patient in relation with the emollient consumption (weight of product and number of applications)
Measured: from baseline to Day84
change in LOCAL SCORing Atopic Dermatitis (LOCAL SCORAD) measure
evaluation of LOCAL SCORAD by the dermatologist in relation with the emollient consumption (weight of product and number of applications)
Measured: from baseline to Day84
change in cutaneous discomfort
evaluation of skin sensation (itching, tingling, burning) by the patient on a 4-point scale (from absence to severe)
Measured: from baseline to Day84
change in global efficacy
evaluation of global efficacy by the patient on a 4-point scale (from nil to excellent)
Measured: from Day28 to Day84
change in global tolerance
evaluation of global tolerance of the treatment (emollient + corticosteroid) by the patient on a 4-point scale (from nil to excellent)
Measured: from Day28 to Day84
change in Patient Benefit Index (PBI) measure
questionnaire filled in by the patient or the patient's parents (whether the statement applies to the situation or not, possible answers: not at all, somewhat, moderately, quite, very, does not apply to me)
Measured: from baseline to Day84
change in the quality of life (patients aged 18 years or over)
questionnaire about the Atopic Burden Scale for Adults (ABS-A) with the following scale: never, rarely, sometimes, often, very often, constantly, not applicable. A higher score means a higher burden.
Measured: from baseline to Day84
change in the quality of life (patients aged less than 18 years)
questionnaire about the Atopic Dermatitis Burden Scale for the Family (ABS-F) with the following scale: no, without hesitation; I don't know; maybe; yes, without hesitation; not applicable. A higher score means a higher burden.
Measured: from baseline to Day84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start14 Oct 2020
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline Le Floc'h, Study director, Cosmetique Active International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644691
- Sponsor's protocol ID
- LRP19002-LIPIKAR BAUME AP+M
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Daily Use of the Tested Emollient on Corticosteroids Consumption in Patients Minimum 3 Years Old With Atopic Dermatitis (SCORAD 20-30) Versus Their Usual Emollient
- ClinicalTrials.gov ID
- NCT05644691
- Acronym / sponsor ID
- LRP19002-LIPIKAR BAUME AP+M
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, corticosteroids, SCORAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.
Detailed description
The study is conducted in compliance, as closely as possible, with the current version of the world medical association declaration of Helsinki, local regulations based on International Council on Harmonisation (ICH) guidelines for Good Clinical Practice.
The primary objective of this study is to compare the tested emollient and the usual emollient through the weight of used dermocorticosteroid. The weight of used dermocorticosteroid is compared at the end of the study by a Student t-test (or a non parametric Wilcoxon test depending on the data distribution).
The following hypotheses are used for the estimation of the sample size calculation:
- Power (1 - β) = 80%
- Two-sided significance level (α) = 5%
- Expected inter-group difference = 0.6g
- Standard deviation = 1.4g.
Statistical analyses is performed with SAS® version 9.4 or higher (SAS institute, North Carolina, USA).
Continuous variables are summarized as number of observations, mean, standard deviation, standard error, median, minimum and maximum (95% confidence interval will be provided if necessary). For categorical variables, subject counts and percentages will be provided.
Analyses use 2-sided tests at the 5% significance level, except the normality tested at the threshold of 1% (Shapiro-Wilk test).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipikar Baume AP+M | – | Other: Lipikar Baume AP+MThe group applies Lipikar Baume AP+M twice daily for 3 months. Participants have 4 visits (Day0, Day 28, Day56, Day84) with different outcome measures including self-evaluations). |
| Usual emollient | – | Other: Usual emollientThe group applies their usual emollient twice daily for 3 months. Participants have 4 visits (Day0, Day28, Day56, Day84 with different outcome measures including self-evaluations). |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients meeting the inclusion and exclusion criteria and agreeing to participate in the study
Key inclusion criteria (3 listed)
- diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features)
- mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion between 20 and 30)
- able to apply the emollient (each morning and evening) during a three-month period
Key exclusion criteria (3 listed)
- presenting with another dermatological condition that could interfere with clinical evaluation
- having received any systemic treatment, including PUVAtherapy for atopic dermatitis in the month prior to Day 0
- who intend to expose themselves to the sun during the trial
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 |
|---|---|---|
| Lipikar Baume AP+Mapplication of Lipikar Baume AP+M twice daily for 3 months in parallel with the corticosteroid treatment | Other | Lipikar Baume AP+M |
| Usual emollientapplication of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment | Other | Usual emollient |
Primary outcome
efficacy of treatments
Time frame: from baseline to Day84
the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications)
9 secondary outcomes
change in SCORing Atopic Dermatitis (SCORAD) measure
Time frame: from baseline to Day84
change in Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) measure
Time frame: from baseline to Day84
change in LOCAL SCORing Atopic Dermatitis (LOCAL SCORAD) measure
Time frame: from baseline to Day84
change in cutaneous discomfort
Time frame: from baseline to Day84
change in global efficacy
Time frame: from Day28 to Day84
change in global tolerance
Time frame: from Day28 to Day84
change in Patient Benefit Index (PBI) measure
Time frame: from baseline to Day84
change in the quality of life (patients aged 18 years or over)
Time frame: from baseline to Day84
change in the quality of life (patients aged less than 18 years)
Time frame: from baseline to Day84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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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.
Caroline Le Floc'h study director
Cosmetique Active International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Cosmetique Active International at 1 site in Slovakia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
efficacy of treatments (time frame: from baseline to Day84). 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 9 Dec 2022.