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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 047_TD Dermatitis cream | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 047_TD Dermatitis cream twice a day for 28 days | Device | 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. |
| 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. |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donatella Mariani | Contact | +41 79 844 2600 | ssu@solarishc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studio Medico Pigatto Bersani | Not yet recruiting | Milan | 20154 | Italy |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 1, 2026 | |
| Reset | Apr 21, 2026 |
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| 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 |
| Poliambulatorio Verona | Recruiting | Verona | 37135 | Italy |
|
| Studio Medico | Not yet recruiting | Voghera | 27058 | Italy |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 1, 2026 | Apr 21, 2026 |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D004485 | Eczema |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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