Dermatitis, ContactNCT07056569
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
A study testing 047_TD Dermatitis cream twice a day for 28 days in people with Dermatitis, Contact and Dermatitis, run by Biokosmes Srl at 3 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Dermatitis, Contact, Dermatitis, Dermatitis, Chronic
- What is being tested?
- 047_TD Dermatitis cream twice a day for 28 days
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesItaly
- Study dates
- 5 Jun 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Not yet recruiting
Studio Medico Pigatto Bersani
Milan, 20154
Paolo Pigatto, Professor, +39 348 704250, pigatto@pigattobersani.it
Paolo Pigatto, Professor
- Recruiting
Poliambulatorio Verona
Verona, 37135
Giampiero Girolomoni, Professor, +39 045 8122547, giampiero.girolomoni@univr.it
Giampiero Girolomoni, Professor
- Not yet recruiting
Studio Medico
Voghera, 27058
Michela Quaglini, Dr., +39 335 563792, m_quaglini@libero.it
Michela Quaglini, Dr.
About this study
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.
Read the detailed 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.
- Conditions
- Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous, Dermatitis, Atopic Dermatitis
- Being tested
- 047_TD Dermatitis cream twice a day for 28 days
- Keywords
- Dermatitis, Atopic dermatitis, Contact dermatitis, Eczematous dermatitis
- Medical subject headings
- Dermatitis, Contact, Dermatitis, Bronchiolitis Obliterans Syndrome, Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
047_TD Dermatitis cream twice a day for 28 daysDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 047_TD Dermatitis cream | Experimental | 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. Receives: Device: 047_TD Dermatitis cream twice a day for 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: End of treatment - 28 days.
Secondary outcomes (10)
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).
Measured: 14 days of treatment
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.
Measured: Treatment day 14 and treatment day 28
Pruritus improvement assessed by VAS
Daily severity pruritus improvement measured by VAS improvement at 14 and 28 days of treatment.
Measured: Treatment day 14 and treatment day 28
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.
Measured: Day 1 of treatment
Long lasting itch relief measured by patient reported assessment
Evaluated via subjective patient/parent/caregiver reported assessment at day 14 and 28 - two times per day (8-10-12h)
Measured: Treatment day 14 and 28
Performance measured by improvement in the Quality of Life
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.
Measured: Treatment day 1, 14 and 28
Subject adherence to treatment
Subject's adherence to treatment will be evaluated from daily diary compilation and product accountability.
Measured: From enrollment to the end of study on day 28
Product usability
Assess through the subject's overall acceptability of the treatment.
Measured: From enrollment to the end of study on day 28
Overall performance of the device
Assessment of the subject's and investigator's global evaluation of the performance of the product by measuring their satisfaction.
Measured: From enrollment to the end of study on day 28
MD Safety evaluation
Evaluation of AE, SAE, ADE, SADE, ASADE, USADE incidence assessed by Investigator and reported according to the current legislation for the whole study period.
Measured: From enrollment to the end of study on day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start5 Jun 2025
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, ContactStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biokosmes Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056569
- Sponsor's protocol ID
- 047 TD - BK2024
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 047 TD - BK2024
- Conditions
- Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous, Dermatitis, Atopic Dermatitis
- Keywords
- Dermatitis, Atopic dermatitis, Contact dermatitis, Eczematous dermatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Biokosmes SrlIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 047_TD Dermatitis cream | Experimental | Device: 047_TD Dermatitis cream twice a day for 28 days047_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. |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 047_TD Dermatitis cream twice a day for 28 days047_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. | Device | 047_TD Dermatitis cream |
Primary outcome
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).
10 secondary outcomes
Performance measured by reduction of disease severity and symptoms at 14 days
Time frame: 14 days of treatment
Eczema improvement assessed by Eczema Area and Severity Index (EASI) score
Time frame: Treatment day 14 and treatment day 28
Pruritus improvement assessed by VAS
Time frame: Treatment day 14 and treatment day 28
Anti-itch effect measured by patient reported assessment
Time frame: Day 1 of treatment
Long lasting itch relief measured by patient reported assessment
Time frame: Treatment day 14 and 28
Performance measured by improvement in the Quality of Life
Time frame: Treatment day 1, 14 and 28
Subject adherence to treatment
Time frame: From enrollment to the end of study on day 28
Product usability
Time frame: From enrollment to the end of study on day 28
Overall performance of the device
Time frame: From enrollment to the end of study on day 28
MD Safety evaluation
Time frame: From enrollment to the end of study on day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 047_TD Dermatitis cream twice a day for 28 days in people with Dermatitis, Contact and Dermatitis, run by Biokosmes Srl at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donatella Mariani (+41 79 844 2600, ssu@solarishc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance measured by reduction of disease severity and symptoms (time frame: End of treatment - 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.