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Tests treatment safety and results for Dermatitis, Contact
Official title 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
ClinicalTrials.gov ID: NCT07056569
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 65
You may be able to join if
- 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
You likely can't join if
- 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...
- A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
- Drug abuser
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
- Verona, Italy
- Voghera, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy; Verona, Italy; Voghera, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.