Ireland
--:--IST
Recruiting Not applicable

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

NCT07056569 · tracked via the Priya Life Science Italy tracker
Sponsor
Biokosmes Srl
Phase
Not applicable
Started
2025-06-05
Last updated
2025-07-09

Condition(s) studied

Dermatitis, ContactDermatitisDermatitis, ChronicDermatitis, EczematousDermatitis, Atopic Dermatitis

Investigational drug(s) / intervention(s)

047_TD Dermatitis cream twice a day for 28 days

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.

Study 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

Sex
ALL
Min age
6 Months
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Performance measured by reduction of disease severity and symptoms — End of treatment - 28 days.
    The evaluation and confirmation of the performance of 047\_TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, through a reduction in disease severity and symptoms at 28 days of treatment, will be assessed by Investigator's Global Assessment (IGA) scores (successful threshold established as reduction of 1 point of the IGA score with respect to baseline value).

Trial sites (3)

FacilityCityRegionStatus
Studio Medico Pigatto Bersani Milan Italy Not Yet Recruiting
Poliambulatorio Verona Verona Italy Recruiting
Studio Medico Voghera Italy Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07056569 on ClinicalTrials.gov ↗ ← All trials in Italy