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Evaluation of the EF192B Protection Versus No Treatment

Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment

NCT06752460•Eurofarma Laboratorios S.A.

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 cracks is confirmed. The barrier formation also guarantees protection against the formation of calluses.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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.
+1 more criteria

Locations (1)

Eurofarma Laboratórios S.A

Itapevi, São Paulo, Brazil

Key Dates

Start Date

August 31, 2025

Primary Completion Date

October 31, 2025

Completion Date

October 31, 2025

Last Updated

December 30, 2024

Enrollment

ESTIMATED participants

Conditions

Skin LesionsSkin Care

Interventions

EF192B

DEVICE

Contacts

Gleyce Lima

CONTACT

+55 11 5090-8411 gleyce.lima@eurofarma.com

Luiza Terranova

CONTACT

+55 11 5090-8421 luiza.terranova@eurofarma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the EF192B Protection Versus No Treatment

Inclusion Criteria

Exclusion Criteria

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