NCT02615561

Brief Summary

  1. 1.Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream).
  2. 2.Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

December 15, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2016

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

October 23, 2015

Last Update Submit

September 14, 2017

Conditions

Dermatitis, Atopic

Keywords

SafetyEfficacyAtopic dermatitisCosmetic products

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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: Percent of subjects with flare-up (Phase 2, only)

    up to 3 months

Secondary Outcomes (4)

  • Safety: Number of adverse events (AE)

    up to 3 months

  • Safety: physical examination

    up to 3 months

  • Safety: vital signs

    up to 3 months

  • Safety: Local tolerability (by AE assessment)

    up to 3 months

Study Arms (3)

Phase 1 (Cure phase)

EXPERIMENTAL

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)

Phase 2 (Care phase) / Arm 1

EXPERIMENTAL

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)

Phase 2 (Care phase) / Arm 2

ACTIVE COMPARATOR

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

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

2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares

Phase 1 (Cure phase)
New cosmetic Bepanthen product: Pumpkin (BAY207543)OTHER

Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject

Phase 2 (Care phase) / Arm 1
Stelatopia (cosmetic comparator)OTHER

Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject

Phase 2 (Care phase) / Arm 2

Eligibility Criteria

Age1 Month - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Karlsruhe, Baden-Wurttemberg, 76189, Germany

Location

Unknown Facility

Kehl, Baden-Wurttemberg, 77694, Germany

Location

Unknown Facility

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

Location

Unknown Facility

Welzheim, Baden-Wurttemberg, 73642, Germany

Location

Unknown Facility

Altdorf B. Nürnberg, Bavaria, 90518, Germany

Location

Unknown Facility

Neustadt / Aisch, Bavaria, 91413, Germany

Location

Unknown Facility

Rosenheim, Bavaria, 83026, Germany

Location

Unknown Facility

Bramsche, Lower Saxony, 49565, Germany

Location

Unknown Facility

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Unknown Facility

Datteln, North Rhine-Westphalia, 45711, Germany

Location

Unknown Facility

Dortmund, North Rhine-Westphalia, 44143, Germany

Location

Unknown Facility

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

Unknown Facility

Neumünster, Schleswig-Holstein, 24534, Germany

Location

Unknown Facility

Erfurt, Thuringia, 99086, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

November 26, 2015

Study Start

December 15, 2015

Primary Completion

September 7, 2016

Study Completion

September 7, 2016

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

DE(14)