check_circleStudy Completed

Dermatitis, atopic

Bayer Identifier:

17534

ClinicalTrials.gov Identifier:

NCT02615561

EudraCT Number:

2015-003485-92

EU CT Number:

Not Available
Curing atopic dermatits in children with a commerical medical device and maintaining healthy skin by using a new cosmetic product

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

1 - 4 Years
  • - 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

  • - 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 summary

Enrollment Goal
136
Trial Dates
December 2015 - September 2016
Phase
N/A
Could I Receive a placebo
No
Products
Bepanthen® Itch Relief Cream (BAY20-7543)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Neumünster, 24534, Germany
Completed
Kehl, 77694, Germany
Completed
Neustadt / Aisch, 91413, Germany
Completed
Neumünster, 24534, Germany
Completed
Altdorf b. Nürnberg, 90518, Germany
Completed
Frankenthal, 67227, Germany
Completed
Bramsche, 49565, Germany
Terminated
Dortmund, 44143, Germany
Completed
Datteln, 45711, Germany
Completed
Neumünster, 24534, Germany
Completed
Schwäbisch Hall, 74523, Germany
Completed
Erfurt, 99086, Germany
Completed
Rosenheim, 83026, Germany
Completed
Bochum, 44791, Germany
Completed
Welzheim, 73642, Germany
Terminated
Karlsruhe, 76189, Germany

Primary Outcome

  • Efficacy: SCORAD with included parameters “extent of disease/area affected” [%] as well as average intensity of pruritus and sleeplessness
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy: Quality of Life according to questionnaire
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy: Intensity of pruritus according to diary
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy: Intensity of sleeplessness according to diary
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy: Time to flare-up (Phase 2, only)
    date_rangeTime Frame:
    up to 3 months
  • Efficacy: Percent of subjects with flare-up (Phase 2, only)
    date_rangeTime Frame:
    up to 3 months

Secondary Outcome

  • Safety: Number of adverse events (AE)
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Safety: physical examination
    Weight and height
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Safety: vital signs
    Systolic and diastolic blood pressure, Heart rate
    date_rangeTime Frame:
    up to 3 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Safety: Local tolerability (by AE assessment)
    date_rangeTime Frame:
    up to 3 months

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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