RecruitingNot Applicable

Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters

Italy90 participantsStarted 2025-06-05

Plain-language summary

The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.

Who can participate

Age range

6 Months – 65 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

. Male/ female \> 6 months \< 65 years
. Patient diagnosed AD/CD
. Patient with EASI max \<16
. Patient with IGA 1-3
. Patient in good condition with no serious systemic disease

Exclusion criteria

. Hypersensitivity to any 047\_TD Dermatitis cream ingredients
. Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator

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

Performance measured by reduction of disease severity and symptoms

Timeframe: End of treatment - 28 days.

Trial details

NCT IDNCT07056569

SponsorBiokosmes Srl

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08

Contact for this trial

Donatella Mariani

+41 79 844 2600 ssu@solarishc.ch

View on ClinicalTrials.gov More Dermatitis, Contact trials