CompletedNot Applicable

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

Germany136 participantsStarted 2015-12-15

Plain-language 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

Who can participate

Age range

1 Month – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness

Timeframe: up to 3 months

Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness

Timeframe: up to 3 months

Efficacy: Quality of Life according to questionnaire

Timeframe: up to 3 months

Efficacy: Intensity of pruritus according to diary

Timeframe: up to 3 months

Efficacy: Intensity of sleeplessness according to diary

Timeframe: 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

Trial details

NCT IDNCT02615561

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09-07

View on ClinicalTrials.gov More Dermatitis, Atopic trials

Who can participate

Age range

1 Month – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness

Timeframe: up to 3 months

Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness

Timeframe: up to 3 months

Efficacy: Quality of Life according to questionnaire

Timeframe: up to 3 months

Efficacy: Intensity of pruritus according to diary

Timeframe: up to 3 months

Efficacy: Intensity of sleeplessness according to diary

Timeframe: 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