Post-marketing follow-up of 047 TD Dermatitis Cream for adults and children with atopic or contact dermatitis
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
This will try 047 TD Dermatitis cream twice a day for 28 days to see if it reduces severity and symptoms in children and adults with atopic or contact dermatitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 6 Months to 65 Years |
| Sex | All |
| Sponsor | Biokosmes Srl Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Milan and 2 other locations) |
| Trial ID | NCT07056569 on ClinicalTrials.gov |
What this trial studies
This interventional post-marketing follow-up tests a topical cream applied twice daily for 28 days in people with clinically confirmed atopic or contact dermatitis. The manufacturer hypothesizes the cream forms a protective layer on treated skin that shields against external factors and reduces symptoms. Data are collected through a PMCF procedure using patient questionnaires from a representative sample, with clinical parameters (EASI and IGA) used to define eligibility and track outcomes. The focus is on performance and safety in a mild-to-moderate dermatitis population seen at outpatient clinics in Italy.
Who should consider this trial
Good fit: Children older than 6 months through adults under 65 with clinically confirmed atopic or contact dermatitis, mild-to-moderate disease (EASI <16, IGA 1–3), and no serious systemic illness are the intended participants.
Not a fit: Patients with more severe dermatitis (EASI ≥16 or IGA >3), those on immunosuppressive therapy, with other interfering skin diseases at the target site, or with known hypersensitivity to the cream ingredients are unlikely to benefit from this product.
Why it matters
Potential benefit: If successful, the cream could offer a safe topical option that reduces redness, itching, and flare severity for people with mild-to-moderate atopic or contact dermatitis.
How similar studies have performed: Topical barrier creams and emollients have a supportive evidence base for symptom relief in dermatitis, though robust published data specific to this exact formulation appear limited and are the purpose of this PMCF.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan and 2 other locations
- Studio Medico Pigatto Bersani — Milan, Italy (Not_yet_recruiting)
- Poliambulatorio Verona — Verona, Italy (Recruiting)
- Studio Medico — Voghera, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Donatella Mariani
- Email: ssu@solarishc.ch
- Phone: +41 79 844 2600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.