Trial Condition(s):

Dermatitis, Atopic

Curing atopic dermatits in children with a commerical medical device and maintaining healthy skin by using a new cosmetic product

Bayer Identifier:

17534

ClinicalTrials.gov Identifier:

NCT02615561

EudraCT Number:

2015-003485-92

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
136
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Bepanthen® Itch Relief Cream (BAY20-7543)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Neumünster, Germany, 24534

Status
Completed
 
Locations

Investigative Site

Kehl, Germany, 77694

Status
Completed
 
Locations

Investigative Site

Neustadt / Aisch, Germany, 91413

Status
Completed
 
Locations

Investigative Site

Altdorf b. Nürnberg, Germany, 90518

Status
Completed
 
Locations

Investigative Site

Frankenthal, Germany, 67227

Status
Completed
 
Locations

Investigative Site

Bramsche, Germany, 49565

Status
Completed
 
Locations

Investigative Site

Dortmund, Germany, 44143

Status
Terminated
 
Locations

Investigative Site

Datteln, Germany, 45711

Status
Completed
 
Locations

Investigative Site

Schwäbisch Hall, Germany, 74523

Status
Completed
 
Locations

Investigative Site

Erfurt, Germany, 99086

Status
Completed
 
Locations

Investigative Site

Rosenheim, Germany, 83026

Status
Completed
 
Locations

Investigative Site

Bochum, Germany, 44791

Status
Completed
 
Locations

Investigative Site

Welzheim, Germany, 73642

Status
Completed
 
Locations

Investigative Site

Karlsruhe, Germany, 76189

Status
Terminated
 

Trial Design