Dermatitis, AtopicNCT03672383
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)
A study testing BAY987534 in people with Dermatitis, Atopic, run by Bayer at 1 site in Germany.
Trial summary
This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- BAY987534
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 17 Sep 2018to 17 Oct 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being willing and able to provide written informed consent to participate in the study;
- Patients with self-reported history of AD (at least one flare up in the past with mild to moderate intensity), but with no flare-up within the last month;
- Patients aged between 18 - 65 years;
- Corneometer value < 35 a.u (on one volar forearm);
- Skin type I-IV (Fitzpatrick et al. 1974);
- Patients willing to adhere to trial procedures;
Show all 12Show fewer
- Patients willing to discontinue the use of own cleansing and cosmetic products (e.g. soaps, creams, moisturizers) in test areas 3 days before Day 1 and throughout the course of the trial;
- Patients willing to stop smoking 2 hours before the instrumental measurements;
- Patients willing not to drink caffeinated beverages 2 hours before the instrumental measurements;
- Patients willing to avoid contact with water in the test areas 2 hours before the instrumental measurements;
- Negative urine pregnancy test (for female patients of child bearing potential);
- Women of child bearing potential have to use reliable methods of contraception with a low failure rate (i.e., less than 1 % per year; implants, injectables, combined oral contraceptives, hormone-based intrauterine-devices, sexual abstinence or vasectomized partner).
Who cannot join
- Any other skin disease on the whole body that would interfere the clinical assessment in the opinion of the Investigator;
- Intake of drugs interfering with the immune system (e.g. corticosteroids, immunosuppressive drugs and antihistamines) within 30 days before screening as well as during the trial (with exception of routine vaccinations);
- Intrarectal or topical corticosteroids (in the test area) within 2 weeks before screening as well as during the trial;
- Known allergies to any of the ingredients of the test product;
- Any use of another topical emollient or other established treatment for atopic dermatitis in the test area;
- Any other adjuvant therapy for atopic dermatitis (UV therapy, probiotics homeopathy etc.);
Show all 21Show fewer
- Patients with a Body Mass Index > 30;
- Diabetes mellitus;
- Patients who use tanning beds regularly within the past 2 years;
- Exposure of the test area to the sun;
- Pregnant or lactating women;
- Moles, tattoos, pigmentation or scars on the forearms that would influence the instrumental measurements;
- Hairy skin on test areas;
- Patients with psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing;
- Patients with any history of drug addiction or alcoholism in the past 3 years;
- Patients with expected poor compliance;
- Patients, who are inmates of psychiatric wards, prison or state institutions;
- Participation in a clinical trial with investigational medicinal products or medical devices within the last 30 days prior to the start of this trial;
- Patients underlying any other restrictions due to the participation in other tests / at other test institutes;
- Employees of the trial sites or of the Sponsor's company;
- Patients that according to the opinion of the Investigator should not participate in the trial for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Observer-blinded, Intra-individual Clinical Trial to Examine the Efficacy and Safety of a New Medical Device (Modified Diprobase Formulation) in Adults With Quiescent Atopic Dermatitis
This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.
- Conditions
- Dermatitis, Atopic
- Being tested
- BAY987534
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY987534Device
Also called modified Diprobase formulation
Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .
| Study group | Role | What they receive |
|---|---|---|
| BAY987534 (Treated Arm) | Experimental | Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied. Receives: Device: BAY987534 |
| Untreated Arm | No intervention | Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of the skin hydration assessed of treatment with the test product compared to untreated
AUC: Area under the curve
Measured: Up to 4 weeks
Secondary outcomes (10)
AUC of the short term skin hydration
Comparison of the test product to untreated
Measured: Day 1
Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.)
Comparison of the test product to untreated based on differences to Baseline as well as the comparison to Baseline
Measured: Up to 4 weeks
Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)
a.u.: arbitrary units
Measured: Up to 4 weeks
Skin pH
Comparison of the test product to untreated based on the differences to Baseline
Measured: Up to 4 weeks
Transepidermal water loss
Comparison of the test product to untreated based on differences to Baseline for SDS (Sodium dodecyl sulfate) unchallenged and SDS challenged skin
Measured: Up to 4 weeks
Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)
Comparison of the test product to untreated
Measured: Up to 8 hours
Water gradient within stratum corneum assessed by Raman Spectrometry
Comparison of the test product to untreated
Measured: Up to 8 hours
Number of participants with adverse events (AEs)
Measured: Up to 4 weeks
Compliance check
The diaries will be collected and checked for compliance and completeness of the daily record
Measured: Day 29
Water content within stratum corneum assessed by Raman Spectrometry (unit: %)
Comparison of the test product to untreated
Measured: Up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start17 Sep 2018
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672383
- Sponsor's protocol ID
- 19689
- Status last verified
- Sep 2019
- First submitted
- 7 Sep 2018
- Last updated
- 4 Sep 2019
- 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 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Observer-blinded, Intra-individual Clinical Trial to Examine the Efficacy and Safety of a New Medical Device (Modified Diprobase Formulation) in Adults With Quiescent Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03672383
- Acronym / sponsor ID
- 19689
- Conditions
- Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 14 Sep 2018 (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 clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY987534 (Treated Arm) | Experimental | Device: BAY987534Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied. |
| Untreated Arm | No intervention | –Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients being willing and able to provide written informed consent to participate in the study;
- Patients with self-reported history of AD (at least one flare up in the past with mild to moderate intensity), but with no flare-up within the last month;
- Patients aged between 18 - 65 years;
- Corneometer value < 35 a.u (on one volar forearm);
- Skin type I-IV (Fitzpatrick et al. 1974);
Key exclusion criteria (21 listed)
- Any other skin disease on the whole body that would interfere the clinical assessment in the opinion of the Investigator;
- Intake of drugs interfering with the immune system (e.g. corticosteroids, immunosuppressive drugs and antihistamines) within 30 days before screening as well as during the trial (with exception of routine vaccinations);
- Intrarectal or topical corticosteroids (in the test area) within 2 weeks before screening as well as during the trial;
- Known allergies to any of the ingredients of the test product;
- Any use of another topical emollient or other established treatment for atopic dermatitis in the test area;
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 |
|---|---|---|
| BAY987534Also: modified Diprobase formulationForm: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks . | Device | BAY987534 (Treated Arm) |
Primary outcome
AUC of the skin hydration assessed of treatment with the test product compared to untreated
Time frame: Up to 4 weeks
AUC: Area under the curve
10 secondary outcomes
AUC of the short term skin hydration
Time frame: Day 1
Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.)
Time frame: Up to 4 weeks
Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)
Time frame: Up to 4 weeks
Skin pH
Time frame: Up to 4 weeks
Transepidermal water loss
Time frame: Up to 4 weeks
Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)
Time frame: Up to 8 hours
Water gradient within stratum corneum assessed by Raman Spectrometry
Time frame: Up to 8 hours
Number of participants with adverse events (AEs)
Time frame: Up to 4 weeks
Compliance check
Time frame: Day 29
Water content within stratum corneum assessed by Raman Spectrometry (unit: %)
Time frame: Up to 8 hours
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 4 Sep 2019.
Related trials for Dermatitis, Atopic
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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?
A study testing BAY987534 in people with Dermatitis, Atopic, run by Bayer 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 12 inclusion and 21 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 4 Sep 2019. 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?
AUC of the skin hydration assessed of treatment with the test product compared to untreated (time frame: Up to 4 weeks). 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 4 Sep 2019.