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

Status

Enrolling

Conditions

Dermatitis, Chronic

Dermatitis

Dermatitis, Contact

Dermatitis, Atopic Dermatitis

Dermatitis, Eczematous

Treatments

Device: 047_TD Dermatitis cream twice a day for 28 days

Study type

Interventional

Funder types

Industry

Identifiers

NCT07056569

047 TD - BK2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

6 months to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male/ female > 6 months < 65 years
Patient diagnosed AD/CD
Patient with EASI max <16
Patient with IGA 1-3
Patient in good condition with no serious systemic disease

Exclusion criteria

Hypersensitivity to any 047_TD Dermatitis cream ingredients
Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
Any other adjuvant therapy for AD/CD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
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
A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
Drug abuser
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
Could not provide written informed consent or parents' informed consent to have their child participate in the study

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

90 participants in 1 patient group

047_TD Dermatitis cream

Experimental group

Description:

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.

Treatment:

Device: 047_TD Dermatitis cream twice a day for 28 days

Trial contacts and locations

Central trial contact

Donatella Mariani

Data sourced from clinicaltrials.gov

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