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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

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

Recruiting
6-65 years
All
Phase N/A

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Overview

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.

Description

The study hypothesis is to demonstrate that 047 TD Dermatitis cream creating a protective layer, on the area where it is applied, which defends the skin from external environmental factors.

The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyze the data needed to study the relationships between different variables.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  1. Hypersensitivity to any 047_TD Dermatitis cream ingredients
  2. Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
  3. Any other adjuvant therapy for AD/CD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
  4. 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
  5. A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
  6. Drug abuser
  7. 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
  8. Could not provide written informed consent or parents' informed consent to have their child participate in the study

Study details
    Dermatitis
    Contact
    Dermatitis
    Dermatitis
    Chronic
    Dermatitis
    Eczematous
    Dermatitis
    Atopic Dermatitis

NCT07056569

Biokosmes Srl

21 October 2025

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