Atopic DermatitisNCT05765461
Effect of Lipikar Baume AP+M on Quality of Life and Pain of Adults With Dryness or Severe Xerosis
An observational study of Atopic Dermatitis and Skin Diseases, run by Cosmetique Active International at 7 sites in 7 countries.
Trial summary
This study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Atopic Dermatitis, Skin Diseases
- How many people
- 4,631 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 31 Dec 2019to 28 Nov 2022
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: patients meeting the inclusion criteria and agreeing to participate in the study
Who may be able to join
- atopic dermatitis or other skin disease with dryness or severe xerosis
Who cannot join
- patients not suffering from atopic dermatitis or other skin disease with dryness or severe xerosis
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Effect of Lipikar Baume AP+M on Quality of Life and Pain Related to Atopic Dermatitis and Other Skin Diseases With Dryness or Severe Xerosis on Adults
This study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. They may be prescribed a corticosteroid upon decision of the dermatologist.
Read the detailed description
The general approach of the statistical methodology is the following:
- The qualitative variables are described with number and percent of each level.
- The quantitative variables are described with mean and standard deviation.
- All statistical hypotheses are performed at the 5% significance level using 2-sided tests.
- Given the large sample size, no normality assessment will be done.
- Mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)*100.
- Due to the high number of zeros at inclusion in the self-assessment quantitative criteria, analyses will concern only patient with an intensity above 0 at inclusion or at final visit.
- Response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits.
- Response rate for satisfaction is the percent of patients declaring being Satisfied or Very satisfied.
- Response rate for tolerance is the percent of patients declaring the tolerance High or Excellent.
- Conditions
- Atopic Dermatitis, Skin Diseases
- Keywords
- atopic dermatitis, severe xerosis, quality of life, dryness
- Medical subject headings
- Dermatitis, Atopic, Skin Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the intensity of skin disease
The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)
Measured: from baseline to Day56
Secondary outcomes (5)
change in the intensity of skin dryness
The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)
Measured: from baseline to Day56
evolution of the inflammatory lesions surface
The dermatologist evaluates the inflammatory lesions surface with the following scale:
- none
- <10%
- [10%;30%[
- >30%
Measured: from baseline to Day56
change in the intensity of pruritus
The dermatologist evaluates the intensity of pruritus on a 5-point scale (from absent to very severe)
Measured: from baseline to Day56
change in the quality of sleep
The dermatologist evaluates the intensity of pruritus on a 5-point scale (from unaffected to very severely affected)
Measured: from baseline to Day56
change in the daily discomfort
The dermatologist evaluates the intensity of the daily discomfort on a 5-point scale (from absent to very severe)
Measured: from baseline to Day56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start31 Dec 2019
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,631 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Delphine Kerob, Study director, Cosmetique Active International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765461
- Sponsor's protocol ID
- LRP20001-LIPIKAR BAUME AP+M
- Status last verified
- Jun 2024
- First submitted
- 1 Mar 2023
- Last updated
- 1 Jul 2024
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lipikar Baume AP+M on Quality of Life and Pain Related to Atopic Dermatitis and Other Skin Diseases With Dryness or Severe Xerosis on Adults
- ClinicalTrials.gov ID
- NCT05765461
- Acronym / sponsor ID
- LRP20001-LIPIKAR BAUME AP+M
- Conditions
- Atopic Dermatitis, Skin Diseases
- Keywords
- atopic dermatitis, severe xerosis, quality of life, dryness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,631 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 13 Mar 2023 (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 evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. They may be prescribed a corticosteroid upon decision of the dermatologist.
Detailed description
The general approach of the statistical methodology is the following:
- The qualitative variables are described with number and percent of each level.
- The quantitative variables are described with mean and standard deviation.
- All statistical hypotheses are performed at the 5% significance level using 2-sided tests.
- Given the large sample size, no normality assessment will be done.
- Mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)*100.
- Due to the high number of zeros at inclusion in the self-assessment quantitative criteria, analyses will concern only patient with an intensity above 0 at inclusion or at final visit.
- Response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits.
- Response rate for satisfaction is the percent of patients declaring being Satisfied or Very satisfied.
- Response rate for tolerance is the percent of patients declaring the tolerance High or Excellent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients meeting the inclusion criteria and agreeing to participate in the study
Key inclusion criteria (1 listed)
- atopic dermatitis or other skin disease with dryness or severe xerosis
Key exclusion criteria (1 listed)
- patients not suffering from atopic dermatitis or other skin disease with dryness or severe xerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in the intensity of skin disease
Time frame: from baseline to Day56
The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)
5 secondary outcomes
change in the intensity of skin dryness
Time frame: from baseline to Day56
evolution of the inflammatory lesions surface
Time frame: from baseline to Day56
change in the intensity of pruritus
Time frame: from baseline to Day56
change in the quality of sleep
Time frame: from baseline to Day56
change in the daily discomfort
Time frame: from baseline to Day56
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 1 Jul 2024.
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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.
Delphine Kerob study director
Cosmetique Active International
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Skin Diseases, run by Cosmetique Active International at 7 sites in 7 countries.
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 1 inclusion and 1 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Croatia, Germany, Portugal, South Africa, Taiwan and 2 more countries. 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?
change in the intensity of skin disease (time frame: from baseline to Day56). 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 1 Jul 2024.