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
Led by Biokosmes Srl · Updated on 2025-07-09
90
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and safety of the medical device 047 TD Dermatitis cream in adults and children with atopic and contact dermatitis. The study aims to confirm that the cream helps improve these skin conditions by reducing disease severity and symptoms. The research uses a post-marketing clinical follow-up method involving questionnaires to collect and analyze patient data scientifically. Participants will apply the 047 TD Dermatitis cream twice daily for 28 days on the affected skin areas. The cream forms a protective layer on the skin to defend against environmental factors. Treatment effects will be assessed at various points during the 28-day period, including at 14 days and at the end of treatment. Participants will be monitored throughout the study with evaluations of eczema severity using the Eczema Area and Severity Index (EASI), itch intensity using a visual analog scale (VAS), and patient-reported assessments of anti-itch effects and quality of life. Adherence to treatment, product usability, overall device performance, and safety will be tracked from enrollment to day 28. The total participation lasts for 28 days with assessments at specified intervals.
CONDITIONS
Brief 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 aged over 6 months and under 65 years
- Diagnosed with atopic dermatitis or contact dermatitis
- Eczema severity with EASI score less than 16
- Investigator Global Assessment (IGA) score between 1 and 3
- Good general health with no serious systemic diseases
You will not qualify if you...
- Hypersensitivity to any ingredients of 047 TD Dermatitis cream
- Presence of other skin diseases at the treatment site that may affect clinical assessment
- Use of other therapies for dermatitis such as UV therapy or probiotics within 30 days before baseline or during the study
- Use of other topical emollients or treatments for dermatitis on flare areas during the study, except usual hygiene products in the diaper area
- Current immunosuppressive drug therapy, chemotherapy, or radiation therapy
- History of drug abuse
- Refusal to participate or inability to provide informed consent (including parental consent for minors under 18)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants apply 047 TD Dermatitis cream twice a day on the affected skin area to relieve dermatitis symptoms.
Visits on Day 1, Day 14, and Day 28 for assessments and questionnaires
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
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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