Back to resultsCuring Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)
New cosmetic Bepanthen product: Pumpkin (BAY207543)
Stelatopia (cosmetic comparator)
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Safety, Efficacy, Atopic dermatitis, Cosmetic products
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Phase 1 (Cure phase)
Phase 2 (Care phase) / Arm 1
Phase 2 (Care phase) / Arm 2
Arm Description
Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2)
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
Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD
Outcomes
Primary Outcome Measures
Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
Efficacy: Quality of Life according to questionnaire
Efficacy: Intensity of pruritus according to diary
Efficacy: Intensity of sleeplessness according to diary
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
Efficacy: Time to flare-up (Phase 2, only)
Efficacy: Percent of subjects with flare-up (Phase 2, only)
Secondary Outcome Measures
Safety: Number of adverse events (AE)
Safety: physical examination
Weight and height
Safety: vital signs
Systolic and diastolic blood pressure, Heart rate
Safety: Local tolerability (by AE assessment)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02615561
Brief Title
Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
September 7, 2016 (Actual)
Study Completion Date
September 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream).
Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Safety, Efficacy, Atopic dermatitis, Cosmetic products
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1 (Cure phase)
Arm Type
Experimental
Arm Description
Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2)
Arm Title
Phase 2 (Care phase) / Arm 1
Arm Type
Experimental
Arm 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
Arm Title
Phase 2 (Care phase) / Arm 2
Arm Type
Active Comparator
Arm Description
Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD
Intervention Type
Device
Intervention Name(s)
Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)
Intervention Description
2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares
Intervention Type
Other
Intervention Name(s)
New cosmetic Bepanthen product: Pumpkin (BAY207543)
Intervention Description
Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
Intervention Type
Other
Intervention Name(s)
Stelatopia (cosmetic comparator)
Intervention Description
Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
Primary Outcome Measure Information:
Title
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
Title
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
Time Frame
up to 3 months
Title
Efficacy: Quality of Life according to questionnaire
Time Frame
up to 3 months
Title
Efficacy: Intensity of pruritus according to diary
Time Frame
up to 3 months
Title
Efficacy: Intensity of sleeplessness according to diary
Time Frame
up to 3 months
Title
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
Time Frame
up to 3 months
Title
Efficacy: Time to flare-up (Phase 2, only)
Time Frame
up to 3 months
Title
Efficacy: Percent of subjects with flare-up (Phase 2, only)
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Safety: Number of adverse events (AE)
Time Frame
up to 3 months
Title
Safety: physical examination
Description
Weight and height
Time Frame
up to 3 months
Title
Safety: vital signs
Description
Systolic and diastolic blood pressure, Heart rate
Time Frame
up to 3 months
Title
Safety: Local tolerability (by AE assessment)
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Karlsruhe
State/Province
Baden-Württemberg
ZIP/Postal Code
76189
Country
Germany
City
Kehl
State/Province
Baden-Württemberg
ZIP/Postal Code
77694
Country
Germany
City
Schwäbisch Hall
State/Province
Baden-Württemberg
ZIP/Postal Code
74523
Country
Germany
City
Welzheim
State/Province
Baden-Württemberg
ZIP/Postal Code
73642
Country
Germany
City
Altdorf b. Nürnberg
State/Province
Bayern
ZIP/Postal Code
90518
Country
Germany
City
Neustadt / Aisch
State/Province
Bayern
ZIP/Postal Code
91413
Country
Germany
City
Rosenheim
State/Province
Bayern
ZIP/Postal Code
83026
Country
Germany
City
Bramsche
State/Province
Niedersachsen
ZIP/Postal Code
49565
Country
Germany
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
City
Datteln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45711
Country
Germany
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44143
Country
Germany
City
Frankenthal
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67227
Country
Germany
City
Neumünster
State/Province
Schleswig-Holstein
ZIP/Postal Code
24534
Country
Germany
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99086
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
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