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 range6 Months – 65 Years

SexALL

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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
✕. Any other adjuvant therapy for AD/CD (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/CD during the study at the site of flares (AD/CD lesions). Exception are usual hygienic products in the diaper area
✕. A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
✕. Drug abuser
✕. Don't accept to attend the study procedures and processes as outlined in the protocol. Parents don't accept for the subject less 18th years old
✕. Could not provide written informed consent or parents' informed consent to have their child participate in the study

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