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

Bayer

Status: Completed

Conditions: Dermatitis, Atopic

Treatments: Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543); Other: New cosmetic Bepanthen product: Pumpkin (BAY207543); Other: Stelatopia (cosmetic comparator)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02615561

17534

2015-003485-92 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 136 patients

Sex: All

Ages: 1 month to 4 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 3 patient groups

Phase 1 (Cure phase)

Experimental group

Description:

Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2)

Treatment:

Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)

Phase 2 (Care phase) / Arm 1

Experimental group

Description:

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

Treatment:

Other: New cosmetic Bepanthen product: Pumpkin (BAY207543)

Phase 2 (Care phase) / Arm 2

Active Comparator group

Description:

Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD

Treatment:

Other: Stelatopia (cosmetic comparator)