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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
Body Lotion, applied twice daily on whole body, for 3 months. Intensive Care, applied as needed on affected body areas.
SGS proderm GmbH
Schenefeld, Germany
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
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
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Subject diary (frequency of flare-ups, required physician visits, required drug administration/use of cortisone, well-being)
Time frame: 85 days of treatment