Skin LesionsSpray BNCT06752460
Evaluation of the EF192B Protection Versus No Treatment
A study testing EF192B in people with Skin Lesions and Skin Care, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
This study was designed with the objective of evaluating the protection potential provided by the experimental product EF192B by evaluating its barrier formation capacity. Once its ability to form a barrier is confirmed, EF192B ability to protect against small skin injuries, such as small cuts, bruises, blisters and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Lesions, Skin Care
- What is being tested?
- EF192B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Aug 2025to 31 Oct 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years old.
- Fitzpatrick skin phototype classification I to IV.
- Presence of intact skin in the test region (right forearm and left forearm for selected participants).
- Agreement to adhere to the study procedures and requirements and attend the institute on the days and times determined for the assessments.
- Signing of the Informed Consent Form (ICF) and the Image Disclosure Consent Form (IDCF) before carrying out any study procedure.
Who cannot join
- Diagnosis of skin diseases such as vitiligo, psoriasis, atopic dermatitis.
- Diagnosis of immunological insufficiency.
- Use of systemic corticosteroids or immunosuppressants.
- Diagnosis of type 1 diabetes mellitus or insulin-dependent diabetes or presence of complications resulting from diabetes (such as retinopathy, nephropathy, neuropathy), presence of diabetes-related dermatoses (such as plantar ulcers, lipoid necrobiosis, granuloma annulare, opportunistic infections), history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma.
- History of reaction to liquid dressings.
- Known hypersensitivity to any ingredients of investigational product formulation.
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- Other diseases or use of drugs that may directly interfere with the study or put the research participant's health at risk.
- Presence of any serious or uncontrolled diseases, at the investigator's discretion.
- Pregnancy or lactation.
- Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may result in direct benefit to the participant.
- Presence of any conditions that, at the investigator's discretion, make the participant unable to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Eurofarma Laboratórios S.A
Itapevi, São Paulo, 06696-000
Gleyce Lima, +55 11 5090-8411, gleyce.lima@eurofarma.com
Luiza Terranova, +55 11 5090-8421, luiza.terranova@eurofarma.com
About this study
Official title: Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment
This study was designed with the objective of evaluating the protection potential provided by the experimental product EF192B by evaluating its barrier formation capacity. Once its ability to form a barrier is confirmed, EF192B ability to protect against small skin injuries, such as small cuts, bruises, blisters and cracks is confirmed. The barrier formation also guarantees protection against the formation of calluses.
- Conditions
- Skin Lesions, Skin Care
- Being tested
- EF192B
- Keywords
- effectiveness, Contact test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF192BDevice
EF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| EF192B | Experimental | Application of the EF192B Receives: Device: EF192B |
| Control area | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of EF192B on the curative effect in the protection of small skin lesions through the formation of a barrier, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Measured: 12 hours
Secondary outcomes (4)
Efficacy of the EF192B in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Measured: 12 hours
Evaluate the efficacy of EF192B barrier formation through the range of transepidermal water loss 3 minutes, 6 hours, and 24 hours after its administration
Evaluation of barrier formation through transepidermal water loss range 3 (±1) minutes, 6 hours (± 10 minutes), and 24 hours (± 30 minutes) after the end of tape stripping versus the measurement obtained immediately after tape stripping (TEWL0)
Measured: 24 hours
Evaluate the efficacy of EF192B barrier formation through the range of corneometry 3 minutes, 6 hours, 12 hours, and 24 hours after its administration
Evaluation of barrier formation through corneometry range 3 (± 1) minutes, 6 hours (± 10 minutes), 12 hours (± 20 minutes), and 24 hours (± 30 minutes) after the end of tape stripping versus the measurement obtained immediately after tape stripping
Measured: 24 hours
Evaluate EF192B water resistance after four washes
Water resistance as assessed by the average range of color change to activated charcoal pigment one (01), two (02), three (03), and four (04) washes after administration of the investigational product
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start31 Aug 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752460
- Sponsor's protocol ID
- EF192B
- Acronym
- Spray B
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment
- ClinicalTrials.gov ID
- NCT06752460
- Acronym / sponsor ID
- Spray B / EF192B
- Conditions
- Skin Lesions, Skin Care
- Keywords
- effectiveness, Contact test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 30 Dec 2024 (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.
This study was designed with the objective of evaluating the protection potential provided by the experimental product EF192B by evaluating its barrier formation capacity. Once its ability to form a barrier is confirmed, EF192B ability to protect against small skin injuries, such as small cuts, bruises, blisters and cracks is confirmed. The barrier formation also guarantees protection against the formation of calluses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EF192B | Experimental | Device: EF192BApplication of the EF192B |
| Control area | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 years old.
- Fitzpatrick skin phototype classification I to IV.
- Presence of intact skin in the test region (right forearm and left forearm for selected participants).
- Agreement to adhere to the study procedures and requirements and attend the institute on the days and times determined for the assessments.
- Signing of the Informed Consent Form (ICF) and the Image Disclosure Consent Form (IDCF) before carrying out any study procedure.
Key exclusion criteria (11 listed)
- Diagnosis of skin diseases such as vitiligo, psoriasis, atopic dermatitis.
- Diagnosis of immunological insufficiency.
- Use of systemic corticosteroids or immunosuppressants.
- Diagnosis of type 1 diabetes mellitus or insulin-dependent diabetes or presence of complications resulting from diabetes (such as retinopathy, nephropathy, neuropathy), presence of diabetes-related dermatoses (such as plantar ulcers, lipoid necrobiosis, granuloma annulare, opportunistic infections), history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma.
- History of reaction to liquid dressings.
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 |
|---|---|---|
| EF192BEF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours. | Device | EF192B |
Primary outcome
Evaluate the effect of EF192B on the curative effect in the protection of small skin lesions through the formation of a barrier, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Time frame: 12 hours
4 secondary outcomes
Efficacy of the EF192B in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Time frame: 12 hours
Evaluate the efficacy of EF192B barrier formation through the range of transepidermal water loss 3 minutes, 6 hours, and 24 hours after its administration
Time frame: 24 hours
Evaluate the efficacy of EF192B barrier formation through the range of corneometry 3 minutes, 6 hours, 12 hours, and 24 hours after its administration
Time frame: 24 hours
Evaluate EF192B water resistance after four washes
Time frame: 12 hours
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 30 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EF192B in people with Skin Lesions and Skin Care, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 11 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: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 Gleyce Lima (+55 11 5090-8411, gleyce.lima@eurofarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of EF192B on the curative effect in the protection of small skin lesions through the formation of a barrier, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration. (time frame: 12 hours). 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 30 Dec 2024.