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

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

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

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543); Other: New cosmetic Bepanthen product: Pumpkin (BAY207543); Other: Stelatopia (cosmetic comparator)

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Karlsruhe, Baden-Württemberg, Germany, 76189
    • Kehl, Baden-Württemberg, Germany, 77694
    • Schwäbisch Hall, Baden-Württemberg, Germany, 74523
    • Welzheim, Baden-Württemberg, Germany, 73642
  • Bayern
    • Altdorf b. Nürnberg, Bayern, Germany, 90518
    • Neustadt / Aisch, Bayern, Germany, 91413
    • Rosenheim, Bayern, Germany, 83026
  • Niedersachsen
    • Bramsche, Niedersachsen, Germany, 49565
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44791
    • Datteln, Nordrhein-Westfalen, Germany, 45711
    • Dortmund, Nordrhein-Westfalen, Germany, 44143
  • Rheinland-Pfalz
    • Frankenthal, Rheinland-Pfalz, Germany, 67227
  • Schleswig-Holstein
    • Neumünster, Schleswig-Holstein, Germany, 24534
  • Thüringen
    • Erfurt, Thüringen, Germany, 99086

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Number of adverse events (AE)		up to 3 months
Safety: physical examination	Weight and height	up to 3 months
Safety: vital signs	Systolic and diastolic blood pressure, Heart rate	up to 3 months
Safety: Local tolerability (by AE assessment)		up to 3 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2015
• Primary Completion (Actual): September 7, 2016
• Study Completion (Actual): September 7, 2016

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Atopic dermatitis; Cosmetic products
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Pantothenic Acid
• Other Study ID Numbers: 17534; 2015-003485-92 (EudraCT Number)