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

Study Overview
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Brief Summary
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Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream). Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product

Official Title
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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

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)
* Other: New cosmetic Bepanthen product: Pumpkin (BAY207543)
* Other: Stelatopia (cosmetic comparator)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 (Cure phase)<br>Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2) | Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)<br>* 2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares<br>|
| Experimental: Phase 2 (Care phase) / Arm 1<br>Efficacy and safety of the new cosmetic Bepanthen test product in maintaining healthy skin in the remission phase after cure of children´s mild AD | Other: New cosmetic Bepanthen product: Pumpkin (BAY207543)<br>* Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject<br>|
| Active Comparator: Phase 2 (Care phase) / Arm 2<br>Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD | Other: Stelatopia (cosmetic comparator)<br>* Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Quality of Life according to questionnaire |  | up to 3 months | 
| Efficacy: Intensity of pruritus according to diary |  | up to 3 months | 
| Efficacy: Intensity of sleeplessness 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: Time to flare-up (Phase 2, only) |  | up to 3 months | 
| Efficacy: Percent of subjects with flare-up (Phase 2, only) |  | up to 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Efficacy, Atopic dermatitis, Cosmetic products