Dermatitis, Atopic
Conditions
Keywords
Safety, Efficacy, Atopic dermatitis, Cosmetic products
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
Interventions
DEVICEBepanthen 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
OTHERNew cosmetic Bepanthen product: Pumpkin (BAY207543)
Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
OTHERStelatopia (cosmetic comparator)
Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 4 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Percent of subjects with flare-up (Phase 2, only) | 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: 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: physical examination | up to 3 months | Weight and height |
| Safety: vital signs | up to 3 months | Systolic and diastolic blood pressure, Heart rate |
| Safety: Local tolerability (by AE assessment) | up to 3 months | — |
| Safety: Number of adverse events (AE) | up to 3 months | — |
Countries
Germany
Outcome results
None listed