Post-marketing follow-up of 047 TD Dermatitis Cream for adults and children with atopic or contact dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Poliambulatorio Verona
  Verona, Italy Recruiting
• Studio Medico Pigatto Bersani
  Milan, Italy Not yet recruiting
• Studio Medico
  Voghera, Italy Not yet recruiting

Study contacts

• Study coordinator: Donatella Mariani
• Email: ssu@solarishc.ch
• Phone: +41 79 844 2600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.