Atopic Dermatitis EczemaNCT04097327
Effect of Ectoin Dermatitis Cream 7% on Skin Hydration and Skin Barrier Function
An observational study of Atopic Dermatitis Eczema, run by Bitop AG at 1 site in Germany.
Trial summary
The aim of this prospective, uncontrolled clinical study is to evaluate the clinical effect of Ectoin® Dermatitis Cream-EHK02 on skin hydration and transepidermal water loss (TEWL) in subjects with atopic dermatitis after single and multiple applications. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- Ectoin Dermatitis Cream 7% (EHK02)
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 23 Aug 2019to 31 Dec 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals diagnosed with atopic dermatitis without flare up (in eczema free interval).
Who may be able to join
- Written informed consent form to participate in the study
- Female or male individual between 18 and 65 years in good general health
- Diagnosed atopic dermatitis for ≥ 6 months, in asymptomatic stage (asymptomatic stage means without flare up at the beginning of the study)
- Willingness of the participants to actively participate in the study and to come to the scheduled visits
- Willingness of the participants to discontinue the application of EHK02 in the test area throughout the course of the study
Who cannot join
- Patient has a skin disease that in the investigator's opinion may interfere with the conduct of the study or the evaluation of the results
- Patient is self-reported to be pregnant, nursing or planning pregnancy during the clinical investigation
- Presence of any disease and/or condition and/or history of diseases and/or conditions that according to the investigator may interfere with the conduct of the investigation or the evaluation of the results (such as abnormal laboratory values, chronic inflammatory diseases, immunosuppressive diseases, autoimmune diseases, malignancies, liver or kidney diseases, severe infectious diseases, systemic diseases)
- Patient has a known allergy against any ingredient of the test products
- Patient is known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
- Patient participates in another clinical trial or has participated in another clinical trial within the last 30 days prior to the first day of investigation
Show all 12Show fewer
- Patient is involved in the organization of the clinical investigation
- Subjects receiving the following topical or systemic treatments: Glucocorticoids and / or anti-histamines during the previous week and during the study, Cough suppressants and/or corticoids during the previous 4 weeks,Retinoids and/or immunosuppressants during the previous 6 months
- Use of skin care products, dermatological therapeutics, shower oils or solarium visits on the test area 7 days prior to the study and during the study
- Swimming or sauna 24 hours prior to the study and during the study
- Hair removal on the tested areas within the study period and within 3 days prior to the study
- Participation in suction blister and UV studies on the tested areas during the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ectoin Dermatitis Cream 7% (EHK02) on Skin Hydration and Skin Barrier Function in Patients With Atopic Dermatitis: a Prospective, Clinical Study
The aim of this prospective, uncontrolled clinical study is to evaluate the clinical effect of Ectoin® Dermatitis Cream-EHK02 on skin hydration and transepidermal water loss (TEWL) in subjects with atopic dermatitis after single and multiple applications. Furthermore, data concerning the subjective impression of the study preparation should be collected.
Read the detailed description
The principle mode of Ectoin is based on the physical interaction of this compatible solute with water. Ectoin® Dermatitis Cream 7% (EHK02) is able to build an Ectoin® Hydro Complex on the skin providing an effective protection against external stress factors, stabilizing the skin barrier and moisturizing the dry skin. In former studies, it has been shown that it can be used for the symptomatic treatment of atopic dermatitis. This study should confirm the efficacy and safety of EHK02.
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- Ectoin Dermatitis Cream 7% (EHK02)
- Keywords
- Ectoin, Ectoin Dermatitis Cream, Atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin Dermatitis Cream 7% (EHK02)Other
Application of Ectoin Dermatitis Cream in accordance with the instructions for use
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean corneometer measurement 8 hours after treatment
Corneometer is a non-invasive instrument that measures barrier function of the skin surface. Change of skin hydration will be assessed comparing values before (initial condition-pretreatment) and after single application. The electrical capacitance of the skin surface will be expressed digitally in arbitrary units. Three measurements will be performed on each test area and the mean will be used to define the skin barrier function of the stratum corneum.
Measured: baseline (pretreatment), 8 hours after first application (post treatment)
Change from baseline in mean tewameter measurement 8 hours after treatment
Transepidermal water loss (TEWL) is affected by environmental factors as humidity, temperature, the time of year (seasonal variation) and the moisture content of the skin (hydration level). Tewameter is a non-invasive instrument that measures skin hydration. Change of skin hydration will be assessed comparing values before (initial condition-pretreatment) and after single application. The TEWL measurement will be measured three times and the mean than will be used to define skin hydration of the stratum corneum. The hydration of the skin surface will be expressed in g/hm².
Measured: baseline (pretreatment), 8 hours after first application (post treatment)
Secondary outcomes (4)
Change in skin hydration over time (1, 8, and 24 hours) after single application compared to initial condition (pretreatment).
Skin hydration will be measured with a Tewameter. Physicians will measure values before (pretreatment), and after 1, 8 and 24 hours (post application).
Measured: baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Change in skin barrier function over time (1, 8, and 24 h) after single application compared to initial condition (pretreatment).
Skin barrier function will be measured with a Corneometer. Physicians will measure values before (pretreatment), and after 1, 8 and 24 hours (post application).
Measured: baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Change from baseline (initial condition) in mean Tewameter measurement 7 days after treatment.
Skin hydration will be measured with a Tewameter. Physicians will measure values before (pretreatment), and 7 days after multiple applications.
Measured: baseline and 7 days after treatment
Change from baseline (initial condition) in mean Corneometer measurement 7 days after treatment.
Skin barrier function will be measured with a Corneometer. Physicians will measure values before (pretreatment), and 7 days after multiple applications.
Measured: baseline and 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start23 Aug 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis EczemaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097327
- Sponsor's protocol ID
- btph-043-2019_EHK02
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2019
- Last updated
- 10 Jan 2020
- 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 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ectoin Dermatitis Cream 7% (EHK02) on Skin Hydration and Skin Barrier Function in Patients With Atopic Dermatitis: a Prospective, Clinical Study
- ClinicalTrials.gov ID
- NCT04097327
- Acronym / sponsor ID
- btph-043-2019_EHK02
- Conditions
- Atopic Dermatitis Eczema
- Keywords
- Ectoin, Ectoin Dermatitis Cream, Atopic dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Sep 2019 (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.
The aim of this prospective, uncontrolled clinical study is to evaluate the clinical effect of Ectoin® Dermatitis Cream-EHK02 on skin hydration and transepidermal water loss (TEWL) in subjects with atopic dermatitis after single and multiple applications. Furthermore, data concerning the subjective impression of the study preparation should be collected.
Detailed description
The principle mode of Ectoin is based on the physical interaction of this compatible solute with water. Ectoin® Dermatitis Cream 7% (EHK02) is able to build an Ectoin® Hydro Complex on the skin providing an effective protection against external stress factors, stabilizing the skin barrier and moisturizing the dry skin. In former studies, it has been shown that it can be used for the symptomatic treatment of atopic dermatitis. This study should confirm the efficacy and safety of EHK02.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with atopic dermatitis without flare up (in eczema free interval).
Key inclusion criteria (5 listed)
- Written informed consent form to participate in the study
- Female or male individual between 18 and 65 years in good general health
- Diagnosed atopic dermatitis for ≥ 6 months, in asymptomatic stage (asymptomatic stage means without flare up at the beginning of the study)
- Willingness of the participants to actively participate in the study and to come to the scheduled visits
- Willingness of the participants to discontinue the application of EHK02 in the test area throughout the course of the study
Key exclusion criteria (12 listed)
- Patient has a skin disease that in the investigator's opinion may interfere with the conduct of the study or the evaluation of the results
- Patient is self-reported to be pregnant, nursing or planning pregnancy during the clinical investigation
- Presence of any disease and/or condition and/or history of diseases and/or conditions that according to the investigator may interfere with the conduct of the investigation or the evaluation of the results (such as abnormal laboratory values, chronic inflammatory diseases, immunosuppressive diseases, autoimmune diseases, malignancies, liver or kidney diseases, severe infectious diseases, systemic diseases)
- Patient has a known allergy against any ingredient of the test products
- Patient is known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
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 |
|---|---|---|
| Ectoin Dermatitis Cream 7% (EHK02)Application of Ectoin Dermatitis Cream in accordance with the instructions for use | Other | – |
Primary outcome
Change from baseline in mean corneometer measurement 8 hours after treatment
Time frame: baseline (pretreatment), 8 hours after first application (post treatment)
Corneometer is a non-invasive instrument that measures barrier function of the skin surface. Change of skin hydration will be assessed comparing values before (initial condition-pretreatment) and after single application. The electrical capacitance of the skin surface will be expressed digitally in arbitrary units. Three measurements will be performed on each test area and the mean will be used to define the skin barrier function of the stratum corneum.
Change from baseline in mean tewameter measurement 8 hours after treatment
Time frame: baseline (pretreatment), 8 hours after first application (post treatment)
Transepidermal water loss (TEWL) is affected by environmental factors as humidity, temperature, the time of year (seasonal variation) and the moisture content of the skin (hydration level). Tewameter is a non-invasive instrument that measures skin hydration. Change of skin hydration will be assessed comparing values before (initial condition-pretreatment) and after single application. The TEWL measurement will be measured three times and the mean than will be used to define skin hydration of the stratum corneum. The hydration of the skin surface will be expressed in g/hm².
4 secondary outcomes
Change in skin hydration over time (1, 8, and 24 hours) after single application compared to initial condition (pretreatment).
Time frame: baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Change in skin barrier function over time (1, 8, and 24 h) after single application compared to initial condition (pretreatment).
Time frame: baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Change from baseline (initial condition) in mean Tewameter measurement 7 days after treatment.
Time frame: baseline and 7 days after treatment
Change from baseline (initial condition) in mean Corneometer measurement 7 days after treatment.
Time frame: baseline and 7 days after treatment
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 10 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Eczema, run by Bitop AG at 1 site in Germany.
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 5 inclusion and 12 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 10 Jan 2020. 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 Germany. 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 from baseline in mean corneometer measurement 8 hours after treatment (time frame: baseline (pretreatment), 8 hours after first application (post treatment)). The study lists 2 primary outcomes in all. 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 10 Jan 2020.