Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product

Multicenter, Two-phase Exploratory Clinical Trial to Examine Efficacy and Safety After Open-label Topical Administration of a Medical Device (Bepanthen Itch Relief Cream) for Treatment of Acute Flare-ups Followed by Topical Administration of a New Cosmetic Bepanthen Product or a Cosmetic Comparator in a Parallel-group, Randomized, Investigator-blinded Care Phase for Skin Care in the Remission Phase in Infants With Mild Atopic Dermatitis

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

Inclusion Criteria:

• Written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol
• Male or female babies/children aged between 1 month and 4 years
• Mild AD presenting a maximum SCORAD of 25 (at Screening and Baseline)
• Acute flare-up phase
• Local SCORAD ≥ 5 on the target area (at Screening and Baseline)
• Skin type I - IV according to Fitzpatrick

Exclusion Criteria:

• Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
• Known allergies to any of the ingredients of the IMPs
• Any other adjuvant therapy for AD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
• Any use of another topical emollient or other established treatment for AD during Phase 1 (cure phase) and Phase 2 (care phase) at the site of flares (AD lesions). Exception are usual hygienic products in the nappy area