NCT02615561

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 1 Month – 4 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DEVICE	Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)	2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares
OTHER	New cosmetic Bepanthen product: Pumpkin (BAY207543)	Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
OTHER	Stelatopia (cosmetic comparator)	Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject

Timeline

• Start date: 2015-12-15
• Primary completion: 2016-09-07
• Completion: 2016-09-07
• First posted: 2015-11-26
• Last updated: 2017-09-15

Locations

14 sites across 1 country: Germany