Evaluation of the Protection of a Liquid Bandage

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.

Study Overview

• Status: Completed
• Conditions: Skin Care
• Intervention / Treatment: Device: Liquid bandage

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 06696-000
    • Eurofarma Laboratórios S.A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

• 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.

Exclusion Criteria

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid bandage; The liquid bandage will be applied after the tape strriping procedure and will be reapplied after 12 hours.	Device: Liquid bandage; Liquid elastic collodion- and benzethonium chloride-based topical solution
No Intervention: Control area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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)	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	12 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse event and treatment discontinuations due to adverse event.	The safety assessment will be based on the safety population, which includes all randomized research participants who receive the first application of the investigational product and who perform at least one safety assessment after randomization	12 hours
Incidence of adverse event and treatment discontinuations due to adverse event.	The safety assessment will be based on the safety population, which includes all randomized research participants who receive the first application of the investigational product and who perform at least one safety assessment after randomization	24 hours

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: effectiveness; Contact test
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: EF 184B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No