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

Biokosmes Srl90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Dermatitis, Contact Dermatitis Dermatitis, Chronic Dermatitis, Eczematous

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: End of treatment - 28 days.

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: From enrollment to the end of study on day 28

Product usability

Assess through the subject's overall acceptability of the treatment.

Time frame: 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.

Time frame: 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.

Time frame: From enrollment to the end of study on day 28

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts