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NCT07056569Recruiting

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

Source: ClinicalTrials.gov · Last updated 9 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
30 Jun 2025
Start date
5 Jun 2025
Primary completion date
31 Aug 2025
Lead sponsor
Biokosmes Srl
NCT number
NCT07056569

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 5 Jun 2025 to the primary completion date, 31 Aug 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any other adjuvant therapy for AD/CD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
  • Drug abuser

Other illness

  • 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
  • A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy

Age

  • 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

Other

  • 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
  • Could not provide written informed consent or parents' informed consent to have their child participate in the study

Who the study is looking for

  • 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

Age in the registry: 6 months to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Studio Medico Pigatto Bersani
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
Poliambulatorio Verona
Coordinator of this site? Confirm its status
VeronaItalyRecruiting
Studio Medico
Coordinator of this site? Confirm its status
VogheraItalyNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.