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

Not Applicable

Completed

• Conditions: Dermatitis, Atopic

• Registration Number: NCT02615561
• Lead Sponsor: Bayer

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-26
• Study Start: 2015-12-15
• Primary Completion: 2016-09-07
• Study Completion: 2016-09-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy: Quality of Life according to questionnaire	up to 3 months
Efficacy: Intensity of pruritus according to diary	up to 3 months
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)	up to 3 months
Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness	up to 3 months
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness	up to 3 months
Efficacy: Time to flare-up (Phase 2, only)	up to 3 months
Efficacy: Intensity of sleeplessness according to diary	up to 3 months
Efficacy: Percent of subjects with flare-up (Phase 2, only)	up to 3 months

Secondary Outcome Measures

Name	Time	Method
Safety: Number of adverse events (AE)	up to 3 months
Safety: vital signs	up to 3 months	Systolic and diastolic blood pressure, Heart rate
Safety: physical examination	up to 3 months	Weight and height
Safety: Local tolerability (by AE assessment)	up to 3 months