Atopic DiathesisNCT05786976
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
A study testing Lotion BNO 3732 and Body Lotion Benchmark product in people with Atopic Diathesis and Eczema-Prone Skin, run by Bionorica SE at 1 site in Germany.
Trial summary
The aim of this study is to compare the efficacy and tolerability of a cosmetic product to one that is already available on the market (benchmark product). Efficacy is assessed by instrumental measurements of skin condition, clinical examinations, and questionnaires. Read more about this study
- Who is it for?
- Ages 6 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Diathesis, Eczema-Prone Skin
- What is being tested?
- Lotion BNO 3732 and Body Lotion Benchmark product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2022to 9 Feb 2022
- 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 6 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Written informed consent of the subject to participate in the study, or, for underage subjects of the parents/ legal guardians to let their child participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits or, for underage subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child
- Female and/or male
- Children from 6 months to 14 years of age and adults between 18 and 65 years of age
- Eczema-prone skin and atopic diathesis, diagnosed by the dermatologist
Who cannot join
- Female subjects: pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
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- Insulin-dependent diabetes mellitus
- One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
- Documented allergies to cosmetic products and/ or ingredients, skin care and/or skin cleansing products
- Wounds, moles, tattoos, scars, excessive hair growth, etc. at the test area that could influence the investigation
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
- Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the efficacy and tolerability of a cosmetic product to one that is already available on the market (benchmark product). Efficacy is assessed by instrumental measurements of skin condition, clinical examinations, and questionnaires.
Read the detailed description
The objective of this exploratory study is to investigate the efficacy and tolerability of a cosmetic product on subjects with atopic dermatitis after 4 weeks of use in comparison to a benchmark product.
The efficacy will be evaluated via instrumental measurements of skin hydration by Corneometer, transepidermal water loss by Tewameter and erythema by Chromameter. Furthermore, the efficacy was evaluated by dermatological assessment using the local SCORing Atopic Dermatitis (SCORAD) rated by a dermatologist in the children, the dermatological assessment rated by a dermatologist (objective) and the dermatological assessment rated by adult subject (subjective) in the test areas, respectively.
Additionally, at the beginning and at the end of the study the Patient-Oriented Eczema Measure (POEM) will be evaluated by the subjects or the subjects' parents/legal guardians by questionnaires.
The SCORAD evaluation and the objective and subjective dermatological assessments will also be used for the tolerability assessment of the test products.
- Conditions
- Atopic Diathesis, Eczema-Prone Skin
- Being tested
- Lotion BNO 3732, Body Lotion Benchmark product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotion BNO 3732Other
Crem body lotion twice daily
Body Lotion Benchmark productOther
Crem body lotion twice daily
| Study group | Role | What they receive |
|---|---|---|
| Lotion BNO 3732 for topical care | Experimental | Not described Receives: Other: Lotion BNO 3732 |
| Body Lotion Benchmark product for topical care | Active comparator | Not described Receives: Other: Body Lotion Benchmark product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in transepidermal water loss (g/m2h)
Measured: 29 days
Mean change from baseline in skin redness by Chromameter
Measured: 29 days
Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])
Measured: 29 days
Changes from baseline in local SCORAD (Scoring Atopic Dermatitis, min=0, max=3; 3=worse outcome) in children
Measured: 29 days
Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist
Measured: 29 days
Changes from baseline in POEM (Patient-oriented eczema measure, min=0, max=28; 28=worse outcome)
Measured: 29 days
Secondary outcomes (5)
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)
Measured: 29 days
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Measured: Day 1, after first application
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Measured: 8 days
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Measured: 29 days
Safety of BNO 3732 measured by reported Adverse Events
Measured: until day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start11 Jan 2022
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DiathesisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intra-individual comparison
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabrina Laing, Dr., Principal investigator, proDERM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786976
- Sponsor's protocol ID
- CSBL01-ICBD
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2023
- Last updated
- 28 Mar 2023
- 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05786976
- Acronym / sponsor ID
- CSBL01-ICBD
- Conditions
- Atopic Diathesis, Eczema-Prone Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 28 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.
The aim of this study is to compare the efficacy and tolerability of a cosmetic product to one that is already available on the market (benchmark product). Efficacy is assessed by instrumental measurements of skin condition, clinical examinations, and questionnaires.
Detailed description
The objective of this exploratory study is to investigate the efficacy and tolerability of a cosmetic product on subjects with atopic dermatitis after 4 weeks of use in comparison to a benchmark product.
The efficacy will be evaluated via instrumental measurements of skin hydration by Corneometer, transepidermal water loss by Tewameter and erythema by Chromameter. Furthermore, the efficacy was evaluated by dermatological assessment using the local SCORing Atopic Dermatitis (SCORAD) rated by a dermatologist in the children, the dermatological assessment rated by a dermatologist (objective) and the dermatological assessment rated by adult subject (subjective) in the test areas, respectively.
Additionally, at the beginning and at the end of the study the Patient-Oriented Eczema Measure (POEM) will be evaluated by the subjects or the subjects' parents/legal guardians by questionnaires.
The SCORAD evaluation and the objective and subjective dermatological assessments will also be used for the tolerability assessment of the test products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- intra-individual comparison
| Arm | Type | Receives |
|---|---|---|
| Lotion BNO 3732 for topical care | Experimental | Other: Lotion BNO 3732 |
| Body Lotion Benchmark product for topical care | Active comparator | Other: Body Lotion Benchmark product |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent of the subject to participate in the study, or, for underage subjects of the parents/ legal guardians to let their child participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits or, for underage subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child
- Female and/or male
- Children from 6 months to 14 years of age and adults between 18 and 65 years of age
- Eczema-prone skin and atopic diathesis, diagnosed by the dermatologist
Key exclusion criteria (12 listed)
- Female subjects: pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to 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 |
|---|---|---|
| Lotion BNO 3732Crem body lotion twice daily | Other | Lotion BNO 3732 for topical care |
| Body Lotion Benchmark productCrem body lotion twice daily | Other | Body Lotion Benchmark product for topical care |
Primary outcome
Mean change from baseline in transepidermal water loss (g/m2h)
Time frame: 29 days
Mean change from baseline in skin redness by Chromameter
Time frame: 29 days
Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])
Time frame: 29 days
Changes from baseline in local SCORAD (Scoring Atopic Dermatitis, min=0, max=3; 3=worse outcome) in children
Time frame: 29 days
Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist
Time frame: 29 days
Changes from baseline in POEM (Patient-oriented eczema measure, min=0, max=28; 28=worse outcome)
Time frame: 29 days
5 secondary outcomes
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)
Time frame: 29 days
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time frame: Day 1, after first application
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time frame: 8 days
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time frame: 29 days
Safety of BNO 3732 measured by reported Adverse Events
Time frame: until day 29
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 28 Mar 2023.
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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.
Sabrina Laing, Dr. principal investigator
proDERM GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotion BNO 3732 and Body Lotion Benchmark product in people with Atopic Diathesis and Eczema-Prone Skin, run by Bionorica SE 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 28 Mar 2023. 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?
Mean change from baseline in transepidermal water loss (g/m2h) (time frame: 29 days). The study lists 6 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 28 Mar 2023.