Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis

Conditions
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Atopic Diathesis, Eczema-prone Skin

Intervention / Treatment
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* Other: Atopi intensive care BNO 3731
* Other: Benchmark product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 6 months to 14 years of age and Adult subjects between 18 and 65 years of age Eczema-prone skin and atopic diathesis, diagnosed by the dermatologist Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intra-individual comparison
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atopi intensive care BNO 3731 for topical use<br> | Other: Atopi intensive care BNO 3731<br>* Crem twice daily<br>|
| Active Comparator: Benchmark skin care product for topical use<br> | Other: Benchmark product<br>* Crem twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |