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
Recruiting · NCT07056569 · Interventional (participants receive a specific treatment) · Lead sponsor: Biokosmes Srl
View the official record on ClinicalTrials.gov →Interventions studied
047_TD Dermatitis cream twice a day for 28 days
What this trial is about
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.
Who can take part
Age range
6 Months to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
3 locations listed.
- Studio Medico Pigatto Bersani - Milan, Italy
- Poliambulatorio Verona - Verona, Italy
- Studio Medico - Voghera, Italy