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NCT Number: NCT07056569

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

047_TD Dermatitis cream twice a day for 28 days

Device

047_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.

Primary outcomes

  1. Performance measured by reduction of disease severity and symptoms

    Time frame: End of treatment - 28 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 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).

Secondary outcomes

  1. Performance measured by reduction of disease severity and symptoms at 14 days

    Time frame: 14 days of treatment

    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).

  2. Eczema improvement assessed by Eczema Area and Severity Index (EASI) score

    Time frame: Treatment day 14 and treatment day 28

    To evaluate the eczema improvement at 14 and 28 days of treatment with Eczema Area and Severity Index (EASI) score.

  3. Pruritus improvement assessed by VAS

    Time frame: Treatment day 14 and treatment day 28

    Daily severity pruritus improvement measured by VAS improvement at 14 and 28 days of treatment.

  4. Anti-itch effect measured by patient reported assessment

    Time frame: Day 1 of treatment

    Evaluated via subjective patient reported assessment the antiitch effect at day 1: immediate action (30sec-5min) and in 30 min.

  5. Long lasting itch relief measured by patient reported assessment

    Time frame: Treatment day 14 and 28

    Evaluated via subjective patient/parent/caregiver reported assessment at day 14 and 28 - two times per day (8-10-12h)

  6. Performance measured by improvement in the Quality of Life

    Time frame: Treatment day 1, 14 and 28

    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.

  7. Subject adherence to treatment

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

    Subject's adherence to treatment will be evaluated from daily diary compilation and product accountability.

  8. Product usability

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

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

  9. Overall performance of the device

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

    Assessment of the subject's and investigator's global evaluation of the performance of the product by measuring their satisfaction.

  10. MD Safety evaluation

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

    Evaluation of AE, SAE, ADE, SADE, ASADE, USADE incidence assessed by Investigator and reported according to the current legislation for the whole study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Donatella Mariani

CONTACT

[email protected]

+41 79 844 2600

Sponsors and collaborators

Lead sponsor

Biokosmes Srl

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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