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Trial record 13 of 32 for:    PANTHENOL

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

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ClinicalTrials.gov Identifier: NCT02615561
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE October 23, 2015
First Posted Date  ICMJE November 26, 2015
Last Update Posted Date September 15, 2017
Actual Study Start Date  ICMJE December 15, 2015
Actual Primary Completion Date September 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • 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 ]
  • Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness [ Time Frame: up to 3 months ]
  • Efficacy: Quality of Life according to questionnaire [ Time Frame: up to 3 months ]
  • Efficacy: Intensity of pruritus according to diary [ Time Frame: up to 3 months ]
  • Efficacy: Intensity of sleeplessness according to diary [ Time Frame: up to 3 months ]
  • Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only) [ Time Frame: up to 3 months ]
  • Efficacy: Time to flare-up (Phase 2, only) [ Time Frame: up to 3 months ]
  • Efficacy: Percent of subjects with flare-up (Phase 2, only) [ Time Frame: up to 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • Efficacy: Time to flare up of new AD symptoms assessed by SCORAD (SCORing AD) index for evaluation of disease improvement after and during treatment [ Time Frame: up to 3 months ]
  • Efficacy: Time to flare up of new AD symptoms assessed by Local SCORAD score for Intensity on a representative lesion [ Time Frame: up to 3 months ]
  • Efficacy: Time to flare up of new AD symptoms assessed by Dryness assessed at single representative lesion [ Time Frame: up to 3 months ]
  • Efficacy: Time to flare up of new AD symptoms assessed by Pruritus assessment in subjects diary [ Time Frame: up to 3 months ]
  • Efficacy: Time to flare up of new AD symptoms assessed by Sleeplessness assessment in subjects diary [ Time Frame: up to 3 months ]
  • Efficacy: Time to flare up of new AD symptoms assessed by Quality of life questionnaire [ Time Frame: up to 3 months ]
Change History Complete list of historical versions of study NCT02615561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • Safety: Number of adverse events (AE) [ Time Frame: up to 3 months ]
  • Safety: physical examination [ Time Frame: up to 3 months ]
    Weight and height
  • Safety: vital signs [ Time Frame: up to 3 months ]
    Systolic and diastolic blood pressure, Heart rate
  • Safety: Local tolerability (by AE assessment) [ Time Frame: up to 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • Safety: Number of adverse events (AE) [ Time Frame: up to 3 months ]
  • Safety: physical examination [ Time Frame: up to 3 months ]
    Weight and height
  • Safety: vital signs [ Time Frame: up to 3 months ]
    Systolic and diastolic blood pressure, Heart rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Device: Bepanthen 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
  • Other: New cosmetic Bepanthen product: Pumpkin (BAY207543)
    Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
  • Other: Stelatopia (cosmetic comparator)
    Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
Study Arms  ICMJE
  • 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)
    Intervention: 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
    Intervention: 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
    Intervention: Other: Stelatopia (cosmetic comparator)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2016)
136
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
120
Actual Study Completion Date  ICMJE September 7, 2016
Actual Primary Completion Date September 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02615561
Other Study ID Numbers  ICMJE 17534
2015-003485-92 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP