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
NCT ID: NCT07056569
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-06-05
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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047_TD Dermatitis cream
047\_TD Dermatitis cream formulation with a film-forming action intended for relieving dermatitis symptoms will be applied twice a day for 28 days on the affected skin zone.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
6 Months
65 Years
ALL
No
Sponsors
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Biokosmes Srl
INDUSTRY
Responsible Party
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Locations
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Studio Medico Pigatto Bersani
Milan, , Italy
Poliambulatorio Verona
Verona, , Italy
Studio Medico
Voghera, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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047 TD - BK2024
Identifier Type: -
Identifier Source: org_study_id
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