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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615561
• Other study ID #: 17534
• Secondary ID: 2015-003485-92
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: September 14, 2017
• Start date: December 15, 2015
• Est. completion date: September 7, 2016

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 7, 2016
• Est. primary completion date: September 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness		up to 3 months
Primary	Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness		up to 3 months
Primary	Efficacy: Quality of Life according to questionnaire		up to 3 months
Primary	Efficacy: Intensity of pruritus according to diary		up to 3 months
Primary	Efficacy: Intensity of sleeplessness according to diary		up to 3 months
Primary	Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)		up to 3 months
Primary	Efficacy: Time to flare-up (Phase 2, only)		up to 3 months
Primary	Efficacy: Percent of subjects with flare-up (Phase 2, only)		up to 3 months
Secondary	Safety: Number of adverse events (AE)		up to 3 months
Secondary	Safety: physical examination	Weight and height	up to 3 months
Secondary	Safety: vital signs	Systolic and diastolic blood pressure, Heart rate	up to 3 months
Secondary	Safety: Local tolerability (by AE assessment)		up to 3 months

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