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.
Male/ female > 6 months < 65 years
Patient diagnosed AD/CD
Patient with EASI max <16
Patient with IGA 1-3
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
Single group
047_TD Dermatitis cream twice a day for 28 days
Device047\_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.
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).
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).
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.
Pruritus improvement assessed by VAS
Daily severity pruritus improvement measured by VAS improvement at 14 and 28 days of treatment.
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.
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