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

ConditionsDermatitis, Contact Dermatitis Dermatitis, Chronic Dermatitis, Eczematous Dermatitis, Atopic Dermatitis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-65

SponsorBiokosmes Srl

About this trial

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.

Eligibility criteria

Qualifiers

Male/ female > 6 months < 65 years

Patient diagnosed AD/CD

Patient with EASI max <16

Patient with IGA 1-3

Disqualifiers

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

Trial design

Treatments tested in this trial

047_TD Dermatitis cream twice a day for 28 days

Treatment groups

90 Participants

are divided into 1 treatment group

Sponsors and collaborators

Biokosmes Srl

Lead sponsor

Source ClinicalTrials.gov