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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
44
Crem body lotion twice daily
Crem body lotion twice daily
SGS proderm GmbH
Schenefeld, Germany
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
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)
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Time frame: 29 days
Safety of BNO 3732 measured by reported Adverse Events
Time frame: until day 29