RecruitingNot ApplicableNCT07056569
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
Sponsor
Biokosmes Srl
Enrollment
90 participants
Start Date
Jun 5, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 6 MonthsMax Age: 65 Years
Inclusion Criteria5
- 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 Criteria8
- 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
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Interventions
DEVICE047_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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07056569
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