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

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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

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)

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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