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

Not Applicable

Recruiting

• Conditions: Dermatitis, Atopic Dermatitis; Dermatitis, Contact; Dermatitis; Dermatitis, Chronic; Dermatitis, Eczematous

• Registration Number: NCT07056569
• Lead Sponsor: Biokosmes Srl

Brief Summary

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.

Detailed Description

The study hypothesis is to demonstrate that 047 TD Dermatitis cream creating a protective layer, on the area where it is applied, which defends the skin from external environmental factors.

The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyze the data needed to study the relationships between different variables.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-05
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-08
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance measured by reduction of disease severity and symptoms	End of treatment - 28 days.	The evaluation and confirmation of the performance of 047_TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, through a reduction in disease severity and symptoms at 28 days of treatment, will be assessed by Investigator's Global Assessment (IGA) scores (successful threshold established as reduction of 1 point of the IGA score with respect to baseline value).

Secondary Outcome Measures

Name	Time	Method
Performance measured by reduction of disease severity and symptoms at 14 days	14 days of treatment	The evaluation and confirmation of the performance of 047_TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, through a reduction in disease severity and symptoms at 14 days of treatment, will be assessed by Investigator's Global Assessment (IGA) scores (successful threshold established as reduction of 1 point of the IGA score with respect to baseline value).
Long lasting itch relief measured by patient reported assessment	Treatment day 14 and 28	Evaluated via subjective patient/parent/caregiver reported assessment at day 14 and 28 - two times per day (8-10-12h)
Eczema improvement assessed by Eczema Area and Severity Index (EASI) score	Treatment day 14 and treatment day 28	To evaluate the eczema improvement at 14 and 28 days of treatment with Eczema Area and Severity Index (EASI) score.
Anti-itch effect measured by patient reported assessment	Day 1 of treatment	Evaluated via subjective patient reported assessment the antiitch effect at day 1: immediate action (30sec-5min) and in 30 min.
Pruritus improvement assessed by VAS	Treatment day 14 and treatment day 28	Daily severity pruritus improvement measured by VAS improvement at 14 and 28 days of treatment.
Performance measured by improvement in the Quality of Life	Treatment day 1, 14 and 28	Improvement in the quality of life of the subject related to their dermatitis will be assessed through the Dermatology Life Quality Index - Infant Dermatology Life Quality Index (DLQI/DLQC) questionnaire.
Subject adherence to treatment	From enrollment to the end of study on day 28	Subject's adherence to treatment will be evaluated from daily diary compilation and product accountability.
Product usability	From enrollment to the end of study on day 28	Assess through the subject's overall acceptability of the treatment.
Overall performance of the device	From enrollment to the end of study on day 28	Assessment of the subject's and investigator's global evaluation of the performance of the product by measuring their satisfaction.
MD Safety evaluation	From enrollment to the end of study on day 28	Evaluation of AE, SAE, ADE, SADE, ASADE, USADE incidence assessed by Investigator and reported according to the current legislation for the whole study period.

Trial Locations

Locations (3)

Studio Medico Pigatto Bersani; 🇮🇹 Milano, Italy

Poliambulatorio Verona; 🇮🇹 Verona, Italy

Studio Medico; 🇮🇹 Voghera, Italy