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

Launched by BIOKOSMES SRL · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a cream called 047 TD Dermatitis cream to see how well it works and how safe it is for treating different types of dermatitis, including atopic and contact dermatitis. Dermatitis is a skin condition that causes redness, itching, and irritation. The study will look at whether using this cream helps reduce these symptoms and improves the overall condition of the skin.

Adults and children older than 6 months and younger than 65 years who have a mild to moderate form of dermatitis may be eligible to join. To participate, patients need to have a confirmed diagnosis and not have any serious health problems or other skin conditions that could affect the results. During the study, participants will use the cream as directed and avoid other treatments for their dermatitis on the affected areas. The study is currently recruiting participants, and those interested will need to provide consent before joining. This trial is important because it helps doctors understand if this cream is a helpful and safe option for people dealing with dermatitis.

Gender

ALL

Eligibility criteria

• 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