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)

Studio Medico Pigatto Bersani

Milan, Italy

Poliambulatorio Verona

Verona, Italy

Studio Medico

Voghera, Italy

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NCT07056569


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