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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotion BNO 3732 for topical care | Experimental |
| |
| Body Lotion Benchmark product for topical care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotion BNO 3732 | Other | Crem body lotion twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in transepidermal water loss (g/m2h) | 29 days | |
| Mean change from baseline in skin redness by Chromameter | 29 days | |
| Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.]) | 29 days | |
| Changes from baseline in local SCORAD (Scoring Atopic Dermatitis, min=0, max=3; 3=worse outcome) in children | 29 days | |
| Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist | 29 days | |
| Changes from baseline in POEM (Patient-oriented eczema measure, min=0, max=28; 28=worse outcome) | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome) | 29 days | |
| Evaluation of products traits via questionnaire (20 questions with different answers, no scales) | Day 1, after first application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabrina Laing, Dr. | proDERM GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm GmbH | Schenefeld | 22869 | Germany |
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intra-individual comparison
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| Body Lotion Benchmark product |
| Other |
Crem body lotion twice daily |
|
| Evaluation of products traits via questionnaire (20 questions with different answers, no scales) | 8 days |
| Evaluation of products traits via questionnaire (20 questions with different answers, no scales) | 29 days |
| Safety of BNO 3732 measured by reported Adverse Events | until day 29 |