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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 047_TD Dermatitis cream twice a day for 28 days.
- Who it may be relevant to
- Registry conditions: Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous. Basic parameters: 6 months — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed 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.
Interventions
- Device 047_TD Dermatitis cream twice a day for 28 days
047\_TD Dermatitis cream will be applied twice a day for 28 days on the affected skin zone in sufficient amount of cream and let it dry.
Primary outcome measures
- Performance measured by reduction of disease severity and symptoms [Time frame: End of treatment - 28 days.]
Secondary outcome measures (10)
- Performance measured by reduction of disease severity and symptoms at 14 days [Time frame: 14 days of treatment]
- Eczema improvement assessed by Eczema Area and Severity Index (EASI) score [Time frame: Treatment day 14 and treatment day 28]
- Pruritus improvement assessed by VAS [Time frame: Treatment day 14 and treatment day 28]
- Anti-itch effect measured by patient reported assessment [Time frame: Day 1 of treatment]
- Long lasting itch relief measured by patient reported assessment [Time frame: Treatment day 14 and 28]
- Performance measured by improvement in the Quality of Life [Time frame: Treatment day 1, 14 and 28]
- Subject adherence to treatment [Time frame: From enrollment to the end of study on day 28]
- Product usability [Time frame: From enrollment to the end of study on day 28]
- Overall performance of the device [Time frame: From enrollment to the end of study on day 28]
- MD Safety evaluation [Time frame: From enrollment to the end of study on day 28]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 3 centers
- Studio Medico Pigatto Bersani — Milan
- Poliambulatorio Verona — Verona
- Studio Medico — Voghera
Identifiers
NCT: NCT07056569 · 047 TD - BK2024