Skin LesionSpray ANCT06731062
Assessment of EF192A Potential Sensitization and Accumulated and Primary Irritability in Controlled/Maximized Conditions
A study testing EF192A and Saline solution in people with Skin Lesion and Skin Lesions, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
The investigational product constitutes a medical device that is freely accessible to consumers and, as such, must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Lesion, Skin Lesions, Skin Care
- What is being tested?
- EF192A and Saline solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jan 2025to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 phototype I to IV.
- Presence of intact skin in the test region.
- Agreement to comply with the study procedures and requirements and attend the institute on the days and times determined for the assessments.
- Signature of the Informed Consent Form (ICF) before carrying out any study procedure.
Who cannot join
- Presence of skin marks in the test region that interfere with the assessment of possible skin reactions (for example, pigmentation disorders, vascular malformations, scars, increased hairiness, large quantities of ephelides and nevus, sunburn).
- Presence of active dermatosis (local or disseminated) that could interfere with the study results.
- istory of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
- History of allergic reactions, irritation or intense sensations of discomfort to topical products such as, for example, cosmetics, health products or medicines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Primary, Accumulated Irritability and Sensitization Potential of EF192A Under Controlled and Maximized Conditions
The investigational product constitutes a medical device that is freely accessible to consumers and, as such, must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market. Therefore, this study was designed to evaluate the biocompatibility of the experimental product, as provided for in legislation.
- Conditions
- Skin Lesion, Skin Lesions, Skin Care
- Being tested
- EF192A, Saline solution
- Keywords
- Contact test, HRIPT, Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF192ADevice
EF192A will be applied through a patch test to the participants' backs for 3 consecutive weeks, with 3 weekly applications. Afterwards, there will be a rest period of between 10 and 15 days. EF192A will be reapplied to the participants' back in a naive area and removed after 48 hours.
Saline solutionDevice
The saline solution will be applied via patch test to the participants' backs for 3 consecutive weeks, with 3 weekly applications. Afterwards, there will be a rest period of between 10 and 15 days. The saline solution will be applied again to the participants' back in a naive area and removed after 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| EF192A | Experimental | EF192A will be distributed on a contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the experimental product. Receives: Device: EF192A |
| Saline Solution | Sham comparator | Saline solution - The sterile saline solution (NaCl 0.9%) will be used as control in another contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the control. Receives: Device: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prove the absence of primary irritability potential of EF192A under maximized conditions
- Occurrence of primary irritation;
- Occurrence of accumulated irritation;
- Occurrence of sensitization;
- Occurrence of AEs ;
- Treatment discontinuations due to AEs.
It is expected that after the study period, the product will be considered safe because it does not promote a positive irritability response and skin sensitization in the study group. No statistical inference analysis will be performed.
The results will be presented in the form of tables demonstrating whether there was a positive response of irritability or skin sensitization in the study group or not. During the study, the regions of the product and control application will be evaluated and if any clinical sign is found, it will be classified according to the scale recommended by the International Contact Dermatitis Research Group - ICDRG.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start20 Jan 2025
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Induction period (3 weeks): the experimental and control product will be applied through a patch test on the participants' back for 3 consecutive weeks, with 3 weekly applications, with the first week being the primary irritation phase and the two consecutive weeks being the accumulated irritation phase. Rest period (10 to 15 days): corresponds to the rest period, when participants will remain without any contact test applied to their back, which will follow the induction period, where there will be no application of the experimental and control product. Challenge period (3 days): the experimental and control product will be applied to the participants' back, in a naïve area. Products will be removed after 48 hours, with readings taking place after removal and approximately 24 hours after removal. This period corresponds to the sensitization phase.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
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
- NCT06731062
- Sponsor's protocol ID
- EF192A
- Acronym
- Spray A
- Status last verified
- Feb 2025
- First submitted
- 9 Dec 2024
- Last updated
- 15 Jun 2025
- 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Primary, Accumulated Irritability and Sensitization Potential of EF192A Under Controlled and Maximized Conditions
- ClinicalTrials.gov ID
- NCT06731062
- Acronym / sponsor ID
- Spray A / EF192A
- Conditions
- Skin Lesion, Skin Lesions, Skin Care
- Keywords
- Contact test, HRIPT, Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 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.
The investigational product constitutes a medical device that is freely accessible to consumers and, as such, must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market. Therefore, this study was designed to evaluate the biocompatibility of the experimental product, as provided for in legislation.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Induction period (3 weeks): the experimental and control product will be applied through a patch test on the participants' back for 3 consecutive weeks, with 3 weekly applications, with the first week being the primary irritation phase and the two consecutive weeks being the accumulated irritation phase. Rest period (10 to 15 days): corresponds to the rest period, when participants will remain without any contact test applied to their back, which will follow the induction period, where there will be no application of the experimental and control product. Challenge period (3 days): the experimental and control product will be applied to the participants' back, in a naïve area. Products will be removed after 48 hours, with readings taking place after removal and approximately 24 hours after removal. This period corresponds to the sensitization phase.
| Arm | Type | Receives |
|---|---|---|
| EF192A | Experimental | Device: EF192AEF192A will be distributed on a contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the experimental product. |
| Saline Solution | Sham comparator | Device: Saline solutionSaline solution - The sterile saline solution (NaCl 0.9%) will be used as control in another contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the control. |
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 phototype I to IV.
- Presence of intact skin in the test region.
- Agreement to comply with the study procedures and requirements and attend the institute on the days and times determined for the assessments.
- Signature of the Informed Consent Form (ICF) before carrying out any study procedure.
Key exclusion criteria (4 listed)
- Presence of skin marks in the test region that interfere with the assessment of possible skin reactions (for example, pigmentation disorders, vascular malformations, scars, increased hairiness, large quantities of ephelides and nevus, sunburn).
- Presence of active dermatosis (local or disseminated) that could interfere with the study results.
- istory of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
- History of allergic reactions, irritation or intense sensations of discomfort to topical products such as, for example, cosmetics, health products or medicines.
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 |
|---|---|---|
| EF192AEF192A will be applied through a patch test to the participants' backs for 3 consecutive weeks, with 3 weekly applications. Afterwards, there will be a rest period of between 10 and 15 days. EF192A will be reapplied to the participants' back in a naive area and removed after 48 hours. | Device | EF192A |
| Saline solutionThe saline solution will be applied via patch test to the participants' backs for 3 consecutive weeks, with 3 weekly applications. Afterwards, there will be a rest period of between 10 and 15 days. The saline solution will be applied again to the participants' back in a naive area and removed after 48 hours. | Device | Saline Solution |
Primary outcome
Prove the absence of primary irritability potential of EF192A under maximized conditions
Time frame: 42 days
* Occurrence of primary irritation; * Occurrence of accumulated irritation; * Occurrence of sensitization; * Occurrence of AEs ; * Treatment discontinuations due to AEs. It is expected that after the study period, the product will be considered safe because it does not promote a positive irritability response and skin sensitization in the study group. No statistical inference analysis will be performed. The results will be presented in the form of tables demonstrating whether there was a positive response of irritability or skin sensitization in the study group or not. During the study, the regions of the product and control application will be evaluated and if any clinical sign is found, it will be classified according to the scale recommended by the International Contact Dermatitis Research Group - ICDRG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EF192A and Saline solution in people with Skin Lesion and Skin Lesions, 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 4 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: finished, as of the sponsor's last update on 15 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prove the absence of primary irritability potential of EF192A under maximized conditions (time frame: 42 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 15 Jun 2025.