Skin CareNCT05888311
Evaluation of the Protection of a Liquid Bandage
A study testing Liquid bandage in people with 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 (Liquid Bandage) by evaluating its barrier formation capacity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Liquid bandage
- 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
- 18 Feb 2025to 28 Mar 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 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.
Show all 11Show fewer
- 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.
About this study
Official title: Randomized, Open Clinical Study to Evaluate the Protective Potential of a Liquid Bandage Based on Liquid Elastic Collodion Versus no Treatment
This study was designed with the objective of evaluating the protection potential provided by the experimental product (Liquid Bandage) by evaluating its barrier formation capacity. Once the product's ability to form a barrier is confirmed, its ability to protect against small skin injuries, such as small cuts and bruises, blisters and cracks, is confirmed. The barrier formation also guarantees protection against the formation of calluses.
- Conditions
- Skin Care
- Being tested
- Liquid bandage
- Keywords
- effectiveness, Contact test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid bandageDevice
Liquid elastic collodion- and benzethonium chloride-based topical solution
| Study group | Role | What they receive |
|---|---|---|
| Liquid bandage | Experimental | The liquid bandage will be applied after the tape strriping procedure and will be reapplied after 12 hours. Receives: Device: Liquid bandage |
| Control area | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Evaluation of barrier formation through transepidermal water loss range 12 hours (± 20 minutes) after the end of tape stripping (TEWL12h) versus the measurement obtained immediately after tape stripping (TEWL0).
Measured: 12 hours
Secondary outcomes (8)
Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 3 minutes after its administration
Evaluation of barrier formation through transepidermal water loss range 3 (±1) minutes after the end of tape stripping (TEWL3min) versus the measurement obtained immediately after tape stripping (TEWL0)
Measured: 3 minutes
Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 6 hours after its administration.
Evaluation of barrier formation through transepidermal water loss range 6 hours (± 10 minutes) after the end of tape stripping (TEWL6h) versus the measurement obtained immediately after tape stripping (TEWL0)
Measured: 6 hours
Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 24 hours after its administration
Evaluation of barrier formation through transepidermal water loss range 24 hours (± 30 minutes) after the end of tape stripping (TEWL6h) versus the measurement obtained immediately after tape stripping (TEWL0)
Measured: 24 hours
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 3 minutes after its administration
Evaluation of barrier formation through corneometry range 3 (± 1) minutes after the end of tape stripping (CM3min) versus the measurement obtained immediately after tape stripping (CM0)
Measured: 3 minutes
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 6 hours after its administration
Evaluation of barrier formation through corneometry range 6 hours (± 10 minutes) after the end of tape stripping (CM6h) versus the measurement obtained immediately after tape stripping (CM0)
Measured: 6 hours
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 12 hours after its administration
Evaluation of barrier formation through corneometry range 12 hours (± 20 minutes) after the end of tape stripping (CM12h) versus the measurement obtained immediately after tape stripping (CM0)
Measured: 12 hours
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 24 hours after its administration
Evaluation of barrier formation through corneometry range 24 hours (± 30 minutes) after the end of tape stripping (CM24h) versus the measurement obtained immediately after tape stripping (CM0)
Measured: 24 hours
Evaluate the investigational product 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 posted5 Jun 2023
- Study start18 Feb 2025
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CareStudies 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 (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
- NCT05888311
- Sponsor's protocol ID
- EF 184B
- Status last verified
- Feb 2025
- First submitted
- 4 May 2023
- Last updated
- 17 Apr 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 17 Apr 2025. 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 a Liquid Bandage Based on Liquid Elastic Collodion Versus no Treatment
- ClinicalTrials.gov ID
- NCT05888311
- Acronym / sponsor ID
- EF 184B
- Conditions
- Skin Care
- Keywords
- effectiveness, Contact test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 5 Jun 2023 (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 (Liquid Bandage) by evaluating its barrier formation capacity. Once the product's ability to form a barrier is confirmed, its ability to protect against small skin injuries, such as small cuts and 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 |
|---|---|---|
| Liquid bandage | Experimental | Device: Liquid bandageThe liquid bandage will be applied after the tape strriping procedure and will be reapplied after 12 hours. |
| 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 |
|---|---|---|
| Liquid bandageLiquid elastic collodion- and benzethonium chloride-based topical solution | Device | Liquid bandage |
Primary outcome
Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Time frame: 12 hours
Evaluation of barrier formation through transepidermal water loss range 12 hours (± 20 minutes) after the end of tape stripping (TEWL12h) versus the measurement obtained immediately after tape stripping (TEWL0).
8 secondary outcomes
Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 3 minutes after its administration
Time frame: 3 minutes
Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 6 hours after its administration.
Time frame: 6 hours
Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 24 hours after its administration
Time frame: 24 hours
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 3 minutes after its administration
Time frame: 3 minutes
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 6 hours after its administration
Time frame: 6 hours
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 12 hours after its administration
Time frame: 12 hours
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 24 hours after its administration
Time frame: 24 hours
Evaluate the investigational product water resistance after four washes
Time frame: 12 hours
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 17 Apr 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 Liquid bandage in people with 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: finished, as of the sponsor's last update on 17 Apr 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. 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?
Efficacy of the investigational product in barrier formation, 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 17 Apr 2025.