Study Completed

Dermatitis, atopic

Bayer Identifier:

17534

ClinicalTrials.gov Identifier:

NCT02615561

EudraCT Number:

2015-003485-92

EU CT Number:

Not Available

Curing atopic dermatits in children with a commerical medical device and maintaining healthy skin by using a new cosmetic product

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

1 - 4 Years

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

Trial summary

Enrollment Goal

136

Trial Dates

December 2015 - September 2016

Phase

N/A

Could I Receive a placebo

Products

Bepanthen® Itch Relief Cream (BAY20-7543)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Neumünster, 24534, Germany
Completed		Kehl, 77694, Germany
Completed		Neustadt / Aisch, 91413, Germany
Completed		Neumünster, 24534, Germany
Completed		Altdorf b. Nürnberg, 90518, Germany
Completed		Frankenthal, 67227, Germany
Completed		Bramsche, 49565, Germany
Terminated		Dortmund, 44143, Germany
Completed		Datteln, 45711, Germany
Completed		Neumünster, 24534, Germany
Completed		Schwäbisch Hall, 74523, Germany
Completed		Erfurt, 99086, Germany
Completed		Rosenheim, 83026, Germany
Completed		Bochum, 44791, Germany
Completed		Welzheim, 73642, Germany
Terminated		Karlsruhe, 76189, Germany

Primary Outcome

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
Safety Issue:
No
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
Time Frame:
up to 3 months
Safety Issue:
No
Efficacy: Quality of Life according to questionnaire
Time Frame:
up to 3 months
Safety Issue:
No
Efficacy: Intensity of pruritus according to diary
Time Frame:
up to 3 months
Safety Issue:
No
Efficacy: Intensity of sleeplessness according to diary
Time Frame:
up to 3 months
Safety Issue:
No
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
Time Frame:
up to 3 months
Safety Issue:
No
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

Secondary Outcome

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

Trial design

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

Trial Type

Interventional

Intervention Type

Device

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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