Tests a dermatitis cream in people with eczema or contact dermatitis
Tests a medical device cream for eczema and contact dermatitis in children and adults.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Milan, Verona, and Voghera, ItalySee the 3 sites
Where in Italy
- Studio Medico Pigatto BersaniMilan, ItalyNot yet recruiting
- Poliambulatorio VeronaVerona, ItalyTaking people
- Studio MedicoVoghera, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biokosmes Srl
- Trial code
- NCT07056569
- Record updated
- 9 July 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Any other adjuvant therapy for AD/CD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study; Drug abuser; 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; A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy; 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; 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; Could not provide written informed consent or parents' informed consent to have their child participate in the study.