Clinical trial NCT02615561: Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Safety
Efficacy
Atopic dermatitis
Cosmetic products
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 136
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness
timeFrame: up to 3 months
measure: Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
timeFrame: up to 3 months
measure: Efficacy: Quality of Life according to questionnaire
timeFrame: up to 3 months
measure: Efficacy: Intensity of pruritus according to diary
timeFrame: up to 3 months
measure: Efficacy: Intensity of sleeplessness according to diary
timeFrame: up to 3 months
measure: Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
timeFrame: up to 3 months
measure: Efficacy: Time to flare-up (Phase 2, only)
timeFrame: up to 3 months
measure: Efficacy: Percent of subjects with flare-up (Phase 2, only)
timeFrame: up to 3 months
Secondary outcomes:
measure: Safety: Number of adverse events (AE)
timeFrame: up to 3 months
measure: Safety: physical examination
timeFrame: up to 3 months
measure: Safety: vital signs
timeFrame: up to 3 months
measure: Safety: Local tolerability (by AE assessment)
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
state: Baden-Württemberg
city: Kehl
country: Germany
state: Baden-Württemberg
city: Schwäbisch Hall
country: Germany
state: Baden-Württemberg
city: Welzheim
country: Germany
state: Baden-Württemberg
city: Altdorf b. Nürnberg
country: Germany
state: Bayern
city: Neustadt / Aisch
country: Germany
state: Bayern
city: Rosenheim
country: Germany
state: Bayern
city: Bramsche
country: Germany
state: Niedersachsen
city: Bochum
country: Germany
state: Nordrhein-Westfalen
city: Datteln
country: Germany
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
state: Rheinland-Pfalz
city: Neumünster
country: Germany
state: Schleswig-Holstein
city: Erfurt
country: Germany
state: Thüringen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: