Trial Condition(s):
Dermatitis, Atopic
Curing atopic dermatits in children with a commerical medical device and maintaining healthy skin by using a new cosmetic product
Bayer Identifier:
17534
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Neumünster, Germany, 24534 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kehl, Germany, 77694 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Neustadt / Aisch, Germany, 91413 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Altdorf b. Nürnberg, Germany, 90518 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankenthal, Germany, 67227 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bramsche, Germany, 49565 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dortmund, Germany, 44143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Datteln, Germany, 45711 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Schwäbisch Hall, Germany, 74523 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erfurt, Germany, 99086 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosenheim, Germany, 83026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bochum, Germany, 44791 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Welzheim, Germany, 73642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlsruhe, Germany, 76189 | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
3
Primary Outcome
- Efficacy: SCORAD with included parameters “extent of disease/area affected” [%] as well as average intensity of pruritus and sleeplessnessTimeframe: up to 3 months
- Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, drynessTimeframe: up to 3 months
- Efficacy: Quality of Life according to questionnaireTimeframe: up to 3 months
- Efficacy: Intensity of pruritus according to diaryTimeframe: up to 3 months
- Efficacy: Intensity of sleeplessness according to diaryTimeframe: up to 3 months
- Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)Timeframe: up to 3 months
- Efficacy: Time to flare-up (Phase 2, only)Timeframe: up to 3 months
- Efficacy: Percent of subjects with flare-up (Phase 2, only)Timeframe: up to 3 months
Secondary Outcome
- Safety: Number of adverse events (AE)Timeframe: up to 3 months
- Safety: physical examinationWeight and heightTimeframe: up to 3 months
- Safety: vital signsSystolic and diastolic blood pressure, Heart rateTimeframe: up to 3 months
- Safety: Local tolerability (by AE assessment)Timeframe: up to 3 months
Additional Information
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