Actively Recruiting
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
Led by Biokosmes Srl · Updated on 2025-07-09
90
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female older than 6 months and younger than 65 years
- Diagnosed with atopic dermatitis or contact dermatitis
- Eczema Area and Severity Index (EASI) score less than 16
- Investigator's Global Assessment (IGA) score between 1 and 3
- Generally in good health with no serious systemic diseases
You will not qualify if you...
- Allergy or hypersensitivity to any ingredient of 047 TD Dermatitis cream
- Presence of other skin diseases at the treatment area that could affect clinical assessment
- Use of additional therapies for atopic or contact dermatitis (such as UV therapy, probiotics, homeopathy) within 30 days before study start or during the study
- Use of other topical treatments or emollients on dermatitis lesions during the study (except usual hygiene products in diaper area)
- Currently receiving immunosuppressive drugs, chemotherapy, or radiation therapy
- History of drug abuse
- Refusal to participate in study procedures or lack of parental consent for minors
- Inability to provide written informed consent or parental consent for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Studio Medico Pigatto Bersani
Milan, Italy, 20154
Not Yet Recruiting
2
Poliambulatorio Verona
Verona, Italy, 37135
Actively Recruiting
3
Studio Medico
Voghera, Italy, 27058
Not Yet Recruiting
Research Team
D
Donatella Mariani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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