1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream). 2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
136
2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares
Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
Unnamed facility
Karlsruhe, Baden-Wurttemberg, Germany
Unnamed facility
Kehl, Baden-Wurttemberg, Germany
Unnamed facility
Schwäbisch Hall, Baden-Wurttemberg, Germany
Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness
Time frame: up to 3 months
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
Time frame: up to 3 months
Efficacy: Quality of Life according to questionnaire
Time frame: up to 3 months
Efficacy: Intensity of pruritus according to diary
Time frame: up to 3 months
Efficacy: Intensity of sleeplessness according to diary
Time frame: up to 3 months
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
Time frame: up to 3 months
Efficacy: Time to flare-up (Phase 2, only)
Time frame: up to 3 months
Efficacy: Percent of subjects with flare-up (Phase 2, only)
Time frame: up to 3 months
Safety: Number of adverse events (AE)
Time frame: up to 3 months
Safety: physical examination
Weight and height
Time frame: up to 3 months
Safety: vital signs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Welzheim, Baden-Wurttemberg, Germany
Unnamed facility
Altdorf B. Nürnberg, Bavaria, Germany
Unnamed facility
Neustadt / Aisch, Bavaria, Germany
Unnamed facility
Rosenheim, Bavaria, Germany
Unnamed facility
Bramsche, Lower Saxony, Germany
Unnamed facility
Bochum, North Rhine-Westphalia, Germany
Unnamed facility
Datteln, North Rhine-Westphalia, Germany
...and 4 more locations
Systolic and diastolic blood pressure, Heart rate
Time frame: up to 3 months
Safety: Local tolerability (by AE assessment)
Time frame: up to 3 months