check_circleStudy Completed
Dermatitis, atopic
Bayer Identifier:
17534
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Curing atopic dermatits in children with a commerical medical device and maintaining healthy skin by using a new cosmetic product
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
2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product
Key Participants Requirements
Sex
BothAge
1 - 4 YearsTrial summary
Enrollment Goal
136Trial Dates
December 2015 - September 2016Phase
N/ACould I Receive a placebo
NoProducts
Bepanthen® Itch Relief Cream (BAY20-7543)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Neumünster, 24534, Germany | |
Completed | Kehl, 77694, Germany | |
Completed | Neustadt / Aisch, 91413, Germany | |
Completed | Neumünster, 24534, Germany | |
Completed | Altdorf b. Nürnberg, 90518, Germany | |
Completed | Frankenthal, 67227, Germany | |
Completed | Bramsche, 49565, Germany | |
Terminated | Dortmund, 44143, Germany | |
Completed | Datteln, 45711, Germany | |
Completed | Neumünster, 24534, Germany | |
Completed | Schwäbisch Hall, 74523, Germany | |
Completed | Erfurt, 99086, Germany | |
Completed | Rosenheim, 83026, Germany | |
Completed | Bochum, 44791, Germany | |
Completed | Welzheim, 73642, Germany | |
Terminated | Karlsruhe, 76189, Germany |
Primary Outcome
- Efficacy: SCORAD with included parameters “extent of disease/area affected” [%] as well as average intensity of pruritus and sleeplessnessdate_rangeTime Frame:up to 3 monthsenhanced_encryptionNoSafety Issue:
- Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, drynessdate_rangeTime Frame:up to 3 monthsenhanced_encryptionNoSafety Issue:
- Efficacy: Quality of Life according to questionnairedate_rangeTime Frame:up to 3 monthsenhanced_encryptionNoSafety Issue:
- Efficacy: Intensity of pruritus according to diarydate_rangeTime Frame:up to 3 monthsenhanced_encryptionNoSafety Issue:
- Efficacy: Intensity of sleeplessness according to diarydate_rangeTime Frame:up to 3 monthsenhanced_encryptionNoSafety Issue:
- Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)date_rangeTime Frame:up to 3 monthsenhanced_encryptionNoSafety Issue:
- Efficacy: Time to flare-up (Phase 2, only)date_rangeTime Frame:up to 3 months
- Efficacy: Percent of subjects with flare-up (Phase 2, only)date_rangeTime Frame:up to 3 months
Secondary Outcome
- Safety: Number of adverse events (AE)date_rangeTime Frame:up to 3 monthsenhanced_encryptionYesSafety Issue:
- Safety: physical examinationWeight and heightdate_rangeTime Frame:up to 3 monthsenhanced_encryptionYesSafety Issue:
- Safety: vital signsSystolic and diastolic blood pressure, Heart ratedate_rangeTime Frame:up to 3 monthsenhanced_encryptionYesSafety Issue:
- Safety: Local tolerability (by AE assessment)date_rangeTime Frame:up to 3 months
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
3