Evaluation of the Protection of a Liquid Bandage

January 30, 2024 updated by: Eurofarma Laboratorios S.A.

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  • Age between 18 and 70 years old.
  • 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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liquid bandage
Will receive the application of the experimental product (liquid bandage) on the area with activated carbon at the beginning (T0) and at the end of visit 1 (T12).
Device: Liquid bandage
Two areas measuring 3.0 cm x 3.0 cm will be randomly demarcated on one of your forearms, with activated carbon applied to both areas. An area to be treated with the experimental product will be determined by randomization.
Other: Activated carbon
Two areas measuring 3.0 cm x 3.0 cm will be randomly demarcated on one of your forearms, with activated carbon applied to both areas. An untreated area (control area) will be determined by randomization.
Other: Control area
will not receive the experimental product over activated carbon.
Other: Activated carbon
Two areas measuring 3.0 cm x 3.0 cm will be randomly demarcated on one of your forearms, with activated carbon applied to both areas. An untreated area (control area) will be determined by randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average variation in color change in relation to the control area 12 hours after application of the experimental product.
Time Frame: 12 hours
Primary efficacy analyzes (barrier formation 12 hours after product application) will be based on the intention-to-treat population, which includes all randomized participants who have data up to at least 12 hours after product application.
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average variation in color change in relation to the control area in 01 washes after applying the experimental product.
Time Frame: 1 hours
Secondary efficacy analyzes (resistance to water barrier formation up to 24 hours after product application) will be based on the per-protocol population, which include all randomized participants who present data for all study assessment times without major protocol violations.
1 hours
Average variation in color change in relation to the control area in 02 washes after applying the experimental product.
Time Frame: 2 hours
Secondary efficacy analyzes (resistance to water barrier formation up to 24 hours after product application) will be based on the per-protocol population, which include all randomized participants who present data for all study assessment times without major protocol violations.
2 hours
Average variation in color change in relation to the control area in 03 washes after applying the experimental product.
Time Frame: 3 hours
Secondary efficacy analyzes (resistance to water barrier formation up to 24 hours after product application) will be based on the per-protocol population, which include all randomized participants who present data for all study assessment times without major protocol violations.
3 hours
Average variation in color change in relation to the control area in 04 washes after applying the experimental product.
Time Frame: 4 hours
Secondary efficacy analyzes (resistance to water barrier formation up to 24 hours after product application) will be based on the per-protocol population, which include all randomized participants who present data for all study assessment times without major protocol violations.
4 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse event and treatment discontinuations due to adverse event.
Time Frame: 12 hours
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.
Time Frame: 24 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

August 30, 2024

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)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Care

Clinical Trials on Liquid bandage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe