Atopic DermatitisAtoCare-OSNCT05790083
Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema
A study testing Body Lotion and Intensive Care in people with Atopic Dermatitis and Eczema-Prone Skin, run by Bionorica SE at 1 site in Germany.
Trial summary
The aim of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Read more about this study
- Who is it for?
- Ages 2 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Eczema-Prone Skin
- What is being tested?
- Body Lotion and Intensive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jan 2023to 30 Mar 2023
- 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 2 to 75 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 underaged 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 underaged 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 2 to 17 years of age and adult subjects between 18 and 75 years of age
- Eczema-prone skin and atopic dermatitis, diagnosed by the dermatologist
Who cannot join
- Female subjects (only of childbearing age): Pregnancy or lactation
- Drug addicts, alcoholics (only adults)
- 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 as well as to ingredients of the test products
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids, cyclosporine, dupilumab) 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, ibuprofen), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
- Any topical medicinal products (e.g. topical corticosteroids, calcineurin inhibitors) at the test area within the last 5 days prior to the start of the study
- Any topical medication at the test area throughout the entire course of the study (except the medication normally used for treatment of atopic eczema)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Short- and Long-Term Skin Efficacy and Tolerability of a Cosmetic Product Combination of Body Lotion and Intensive Care Over 3 Months in Subjects With Atopic Eczema
The aim of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Efficacy is assessed by instrumental measurements of skin condition (sub-panel), clinical examinations, and questionnaires.
Read the detailed description
The objective of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use.
For efficacy and tolerability evaluation, an objective dermatological assessment will be performed, in addition to assessing efficacy, the severity of atopic eczema will be assessed using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Further, the effect of the test product combination on symptom severity, disease control (recap of atopic eczema (RECAP)), quality of life and well-being will be evaluated by the subjects or the subjects' parents/ legal guardians. The subjects or the subjects' parents/ legal guardians will also document the frequency of flare-ups, required physician visits and the use of cortisone administration as well as their/ their child's well-being in a diary.
Additionally, the influence of the test product combination on the skin barrier will be assessed in a sub-panel with dry legs by measuring the transepidermal water loss by Aquaflux and by sampling of biological material for analysis of skin lipids and corneocyte maturity before and after 3 months of product use.
- Conditions
- Atopic Dermatitis, Eczema-Prone Skin
- Being tested
- Body Lotion and Intensive Care
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Lotion and Intensive CareOther
Body Lotion, applied twice daily on whole body, for 3 months. Intensive Care, applied as needed on affected body areas.
| Study group | Role | What they receive |
|---|---|---|
| Body Lotion BNO 3732 + Intensive Care BNO 3731 | Experimental | Not described Receives: Other: Body Lotion and Intensive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Measured: 85 days of treatment
Change from baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM, (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Measured: 85 days of treatment
Change from baseline in Recap of atopic eczema (RECAP, min = 0, max = 4; 4 = worst outcome) to Day 29, Day 57 and Day 85
Measured: 85 days of treatment
Change from baseline in Dermatology Life Quality Index (DLQI, 10 closed questions with varying scales) to Day 29, Day 57 and Day 85
Measured: 85 days of treatment
Secondary outcomes (5)
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (no scales) to Day 29, Day 57 and Day 85
Measured: 85 days of treatment
Evaluation of product traits via questionnaire (7 questions with different answers, no scales) on day 1 and after 29, 57, 85 days
Measured: 85 days of treatment
Sub-group: mean change from baseline in transepidermal water loss (g/m2h), Lipid contents (ng/133mm²) and Morphological analysis (length of lipid lamellae, nm/1.000nm²) to Day 85
Measured: 85 days of treatment
Safety of BNO 3732 and BNO 3731 measured by reported Adverse Events to Day 85
Measured: 85 days of treatment
Subject diary (frequency of flare-ups, required physician visits, required drug administration/use of cortisone, well-being)
Measured: 85 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start3 Jan 2023
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katrin Unbereit, Dr., Principal investigator, proDERM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790083
- Sponsor's protocol ID
- AtoCare-OS
- Acronym
- AtoCare-OS
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 29 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Short- and Long-Term Skin Efficacy and Tolerability of a Cosmetic Product Combination of Body Lotion and Intensive Care Over 3 Months in Subjects With Atopic Eczema
- ClinicalTrials.gov ID
- NCT05790083
- Acronym / sponsor ID
- AtoCare-OS / AtoCare-OS
- Conditions
- Atopic Dermatitis, Eczema-Prone Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 29 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 exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Efficacy is assessed by instrumental measurements of skin condition (sub-panel), clinical examinations, and questionnaires.
Detailed description
The objective of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use.
For efficacy and tolerability evaluation, an objective dermatological assessment will be performed, in addition to assessing efficacy, the severity of atopic eczema will be assessed using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Further, the effect of the test product combination on symptom severity, disease control (recap of atopic eczema (RECAP)), quality of life and well-being will be evaluated by the subjects or the subjects' parents/ legal guardians. The subjects or the subjects' parents/ legal guardians will also document the frequency of flare-ups, required physician visits and the use of cortisone administration as well as their/ their child's well-being in a diary.
Additionally, the influence of the test product combination on the skin barrier will be assessed in a sub-panel with dry legs by measuring the transepidermal water loss by Aquaflux and by sampling of biological material for analysis of skin lipids and corneocyte maturity before and after 3 months of product use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Lotion BNO 3732 + Intensive Care BNO 3731 | Experimental | Other: Body Lotion and Intensive Care |
Who may qualify
- Ages
- 2 to 75 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 underaged 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 underaged 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 2 to 17 years of age and adult subjects between 18 and 75 years of age
- Eczema-prone skin and atopic dermatitis, diagnosed by the dermatologist
Key exclusion criteria (14 listed)
- Female subjects (only of childbearing age): Pregnancy or lactation
- Drug addicts, alcoholics (only adults)
- 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 |
|---|---|---|
| Body Lotion and Intensive CareBody Lotion, applied twice daily on whole body, for 3 months. Intensive Care, applied as needed on affected body areas. | Other | Body Lotion BNO 3732 + Intensive Care BNO 3731 |
Primary outcome
Change from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Time frame: 85 days of treatment
Change from baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM, (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Time frame: 85 days of treatment
Change from baseline in Recap of atopic eczema (RECAP, min = 0, max = 4; 4 = worst outcome) to Day 29, Day 57 and Day 85
Time frame: 85 days of treatment
Change from baseline in Dermatology Life Quality Index (DLQI, 10 closed questions with varying scales) to Day 29, Day 57 and Day 85
Time frame: 85 days of treatment
5 secondary outcomes
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (no scales) to Day 29, Day 57 and Day 85
Time frame: 85 days of treatment
Evaluation of product traits via questionnaire (7 questions with different answers, no scales) on day 1 and after 29, 57, 85 days
Time frame: 85 days of treatment
Sub-group: mean change from baseline in transepidermal water loss (g/m2h), Lipid contents (ng/133mm²) and Morphological analysis (length of lipid lamellae, nm/1.000nm²) to Day 85
Time frame: 85 days of treatment
Safety of BNO 3732 and BNO 3731 measured by reported Adverse Events to Day 85
Time frame: 85 days of treatment
Subject diary (frequency of flare-ups, required physician visits, required drug administration/use of cortisone, well-being)
Time frame: 85 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Katrin Unbereit, 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 Body Lotion and Intensive Care in people with Atopic Dermatitis 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 14 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: status not confirmed, as of the sponsor's last update on 29 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?
Results are not available in the source record.
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 objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85 (time frame: 85 days of treatment). The study lists 4 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 29 Mar 2023.