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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dermatitis, Atopic
- Sponsor
- Bayer
- Enrollment
- 136
- Primary Endpoint
- Efficacy: Quality of Life according to questionnaire
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
- Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream).
- Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product
Investigators
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
Outcomes
Primary Outcomes
Efficacy: Quality of Life according to questionnaire
Time Frame: up to 3 months
Efficacy: Intensity of pruritus according to diary
Time Frame: up to 3 months
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
Time Frame: up to 3 months
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
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
Time Frame: up to 3 months
Efficacy: Time to flare-up (Phase 2, only)
Time Frame: up to 3 months
Efficacy: Intensity of sleeplessness according to diary
Time Frame: up to 3 months
Efficacy: Percent of subjects with flare-up (Phase 2, only)
Time Frame: up to 3 months
Secondary Outcomes
- Safety: Number of adverse events (AE)(up to 3 months)
- Safety: vital signs(up to 3 months)
- Safety: physical examination(up to 3 months)
- Safety: Local tolerability (by AE assessment)(up to 3 months)