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.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis; Dermatitis, Contact; Dermatitis, Eczematous; Dermatitis, Chronic; Dermatitis, Atopic Dermatitis
• Intervention / Treatment: Device: 047_TD Dermatitis cream twice a day for 28 days

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donatella Mariani; Phone Number: +41 79 844 2600; Email: ssu@solarishc.ch

Study Locations

• Italy
  • Milano, Italy, 20154
    • Not yet recruiting
    • Studio Medico Pigatto Bersani
    • Contact: Paolo Pigatto, Professor; Phone Number: +39 348 704250; Email: pigatto@pigattobersani.it
    • Principal Investigator: Paolo Pigatto, Professor
  • Verona, Italy, 37135
    • Recruiting
    • Poliambulatorio Verona
    • Contact: Giampiero Girolomoni, Professor; Phone Number: +39 045 8122547; Email: giampiero.girolomoni@univr.it
    • Principal Investigator: Giampiero Girolomoni, Professor
  • Voghera, Italy, 27058
    • Not yet recruiting
    • Studio Medico
    • Contact: Michela Quaglini, Dr.; Phone Number: +39 335 563792; Email: m_quaglini@libero.it
    • Principal Investigator: Michela Quaglini, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 047_TD Dermatitis cream; 047_TD Dermatitis cream formulation with a film-forming action intended for relieving dermatitis symptoms will be applied twice a day for 28 days on the affected skin zone.	Device: 047_TD Dermatitis cream twice a day for 28 days; 047_TD Dermatitis cream will be applied twice a day for 28 days on the affected skin zone in sufficient amount of cream and let it dry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance measured by reduction of disease severity and symptoms	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).	End of treatment - 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance measured by reduction of disease severity and symptoms at 14 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 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).	14 days of treatment
Eczema improvement assessed by Eczema Area and Severity Index (EASI) score	To evaluate the eczema improvement at 14 and 28 days of treatment with Eczema Area and Severity Index (EASI) score.	Treatment day 14 and treatment day 28
Pruritus improvement assessed by VAS	Daily severity pruritus improvement measured by VAS improvement at 14 and 28 days of treatment.	Treatment day 14 and treatment day 28
Anti-itch effect measured by patient reported assessment	Evaluated via subjective patient reported assessment the antiitch effect at day 1: immediate action (30sec-5min) and in 30 min.	Day 1 of treatment
Long lasting itch relief measured by patient reported assessment	Evaluated via subjective patient/parent/caregiver reported assessment at day 14 and 28 - two times per day (8-10-12h)	Treatment day 14 and 28
Performance measured by improvement in the Quality of Life	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.	Treatment day 1, 14 and 28
Subject adherence to treatment	Subject's adherence to treatment will be evaluated from daily diary compilation and product accountability.	From enrollment to the end of study on day 28
Product usability	Assess through the subject's overall acceptability of the treatment.	From enrollment to the end of study on day 28
Overall performance of the device	Assessment of the subject's and investigator's global evaluation of the performance of the product by measuring their satisfaction.	From enrollment to the end of study on day 28
MD Safety evaluation	Evaluation of AE, SAE, ADE, SADE, ASADE, USADE incidence assessed by Investigator and reported according to the current legislation for the whole study period.	From enrollment to the end of study on day 28

Collaborators and Investigators

• Sponsor: Biokosmes Srl

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 30, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Atopic dermatitis; Dermatitis; Contact dermatitis; Eczematous dermatitis
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Dermatitis, Contact
• Other Study ID Numbers: 047 TD - BK2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No