An interventional study of 047_TD Dermatitis cream twice a day for 28 days in Dermatitis, Contact, Dermatitis and Dermatitis, Chronic, sponsored by Biokosmes Srl. Recruiting at 3 sites in Italy. Open to participants aged 6 Months to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Biokosmes Srl · Not applicable, Interventional, and Supportive care
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.
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.
61 studies on the registry are indexed under Dermatitis, Contact; 8 are open to participants now.
This study's planned enrollment of 90 is above the median of 47 across 49 interventional studies indexed under Dermatitis, Contact.
Browse Dermatitis, Contact studies →Biokosmes Srl is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 047_TD Dermatitis cream twice a day for 28 days
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.
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).
Time frame: End of treatment - 28 days.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of study on day 28
Product usability
Assess through the subject's overall acceptability of the treatment.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of study on day 28
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Aug 2025, 2 months after the start.
Of 21 interventional studies with no phase under Dermatitis, Contact, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 21. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
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