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

Last updated: June 30, 2025
Sponsor: Biokosmes Srl
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atopic Dermatitis

Dermatitis, Atopic

Rash

Treatment

047_TD Dermatitis cream twice a day for 28 days

Clinical Study ID

NCT07056569
047 TD - BK2024
  • Ages 6-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Hypersensitivity to any 047_TD Dermatitis cream ingredients

  2. Any other skin disease at the target area that would interfere the clinicalassessment 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 duringthe study at the site of flares (AD/CD lesions). Exception are usual hygienicproducts in the diaper area

  5. A history of currently undergoing immunosuppressive drug therapy, chemotherapy, orradiation therapy

  6. Drug abuser

  7. Don't accept to attend the study procedures and processes as outlined in theprotocol. Parents don't accept for the subject less 18th years old

  8. Could not provide written informed consent or parents' informed consent to havetheir child participate in the study

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: 047_TD Dermatitis cream twice a day for 28 days
Phase:
Study Start date:
June 05, 2025
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Studio Medico Pigatto Bersani

    Milano, 20154
    Italy

    Site Not Available

  • Poliambulatorio Verona

    Verona, 37135
    Italy

    Active - Recruiting

  • Studio Medico

    Voghera, 27058
    Italy

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.