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CompletedNCT02615561Updated Sep 15, 2017

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

An interventional study of Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543) and New cosmetic Bepanthen product: Pumpkin (BAY207543) in Dermatitis, Atopic, sponsored by Bayer. Completed at 14 sites in Germany. Open to participants aged 1 Month to 4 Years. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by Bayer · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
1 Month to 4 Years
Sex
All
01

Study 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
02

Conditions studied

  • Dermatitis, Atopic

Keywords

  • Safety
  • Efficacy
  • Atopic dermatitis
  • Cosmetic products
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 136 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 4 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    Phase 1 (Cure phase)

    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)

  • Experimental
    Phase 2 (Care phase) / Arm 1

    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)

  • Active comparator
    Phase 2 (Care phase) / Arm 2

    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)

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

06

What researchers measure

Primary outcomes

  1. Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness

    Time frame: up to 3 months

  2. Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness

    Time frame: up to 3 months

  3. Efficacy: Quality of Life according to questionnaire

    Time frame: up to 3 months

  4. Efficacy: Intensity of pruritus according to diary

    Time frame: up to 3 months

  5. Efficacy: Intensity of sleeplessness according to diary

    Time frame: up to 3 months

  6. Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)

    Time frame: up to 3 months

  7. Efficacy: Time to flare-up (Phase 2, only)

    Time frame: up to 3 months

  8. Efficacy: Percent of subjects with flare-up (Phase 2, only)

    Time frame: up to 3 months

Secondary outcomes

  1. Safety: Number of adverse events (AE)

    Time frame: up to 3 months

  2. Safety: physical examination

    Weight and height

    Time frame: up to 3 months

  3. Safety: vital signs

    Systolic and diastolic blood pressure, Heart rate

    Time frame: up to 3 months

  4. Safety: Local tolerability (by AE assessment)

    Time frame: up to 3 months

07

Study locations

14 sites
  • Karlsruhe, Baden-Württemberg 76189, Germany
  • Kehl, Baden-Württemberg 77694, Germany
  • Schwäbisch Hall, Baden-Württemberg 74523, Germany
  • Welzheim, Baden-Württemberg 73642, Germany
  • Altdorf b. Nürnberg, Bayern 90518, Germany
  • Neustadt / Aisch, Bayern 91413, Germany
  • Rosenheim, Bayern 83026, Germany
  • Bramsche, Niedersachsen 49565, Germany
  • Bochum, Nordrhein-Westfalen 44791, Germany
  • Datteln, Nordrhein-Westfalen 45711, Germany
  • Dortmund, Nordrhein-Westfalen 44143, Germany
  • Frankenthal, Rheinland-Pfalz 67227, Germany
  • Neumünster, Schleswig-Holstein 24534, Germany
  • Erfurt, Thüringen 99086, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02615561
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Nov 26, 2015
Start date
Dec 15, 2015
Primary completion
Sep 7, 2016
Completion
Sep 7, 2016
Last update
Sep 15, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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