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The aim of this study is to compare the efficacy and tolerability and 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 5 days 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 as well as by evaluation of itch by using a Numerical Rating Scale (NRS). For efficacy and tolerability evaluation an objective and, in the case of adults, an additional subjective dermatological assessment will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atopi intensive care BNO 3731 for topical use | Experimental |
| |
| Benchmark skin care product for topical use | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atopi intensive care BNO 3731 | Other | Crem twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in transepidermal water loss (g/m2h) | after 6 days of treatment | |
| Mean change from baseline in skin redness by Chromameter | after 6 days of treatment | |
| Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.]) | after 6 days of treatment | |
| Changes 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=worse outcome) | after 6 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome) | after 6 days of treatment | |
| Subjective evaluation of itch on Numeric Rating Scale (NRS-11) (min= 0, max=10, 10 = worst imaginable itch) |
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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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| Benchmark product |
| Other |
Crem twice daily |
|
| every day, day 1 until 6 days of treatment |
| Evaluation of products traits via questionnaire (20 questions with different answers, no scales) | after 6 days of treatment |
| Safety of BNO 3732 measured by reported Adverse Events | until day 29 |