Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543) Other: New cosmetic Bepanthen product: Pumpkin (BAY207543) Other: Stelatopia (cosmetic comparator) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : September 7, 2016
Actual Study Completion Date : September 7, 2016


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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Safety: Number of adverse events (AE) [ Time Frame: up to 3 months ]
  2. Safety: physical examination [ Time Frame: up to 3 months ]
    Weight and height

  3. Safety: vital signs [ Time Frame: up to 3 months ]
    Systolic and diastolic blood pressure, Heart rate

  4. Safety: Local tolerability (by AE assessment) [ Time Frame: up to 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615561


Locations
Layout table for location information
Germany
Karlsruhe, Baden-Württemberg, Germany, 76189
Kehl, Baden-Württemberg, Germany, 77694
Schwäbisch Hall, Baden-Württemberg, Germany, 74523
Welzheim, Baden-Württemberg, Germany, 73642
Altdorf b. Nürnberg, Bayern, Germany, 90518
Neustadt / Aisch, Bayern, Germany, 91413
Rosenheim, Bayern, Germany, 83026
Bramsche, Niedersachsen, Germany, 49565
Bochum, Nordrhein-Westfalen, Germany, 44791
Datteln, Nordrhein-Westfalen, Germany, 45711
Dortmund, Nordrhein-Westfalen, Germany, 44143
Frankenthal, Rheinland-Pfalz, Germany, 67227
Neumünster, Schleswig-Holstein, Germany, 24534
Erfurt, Thüringen, Germany, 99086
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02615561     History of Changes
Other Study ID Numbers: 17534
2015-003485-92 ( EudraCT Number )
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Keywords provided by Bayer:
Safety
Efficacy
Atopic dermatitis
Cosmetic products
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pantothenic Acid
Diphenhydramine
Promethazine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists