Evaluation of the EF192B Protection Versus No Treatment (Spray B)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Care; Skin Lesions
• Intervention / Treatment: Device: EF192B

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

Contacts and Locations

• Study Contact: Name: Gleyce Lima; Phone Number: +55 11 5090-8411; Email: gleyce.lima@eurofarma.com
• Study Contact Backup: Name: Luiza Terranova; Phone Number: +55 11 5090-8421; Email: luiza.terranova@eurofarma.com

Study Locations

• Brazil
  • São Paulo
    • Itapevi, São Paulo, Brazil, 06696-000
      • Eurofarma Laboratórios S.A
      • Contact: Gleyce Lima; Phone Number: +55 11 5090-8411; Email: gleyce.lima@eurofarma.com
      • Contact: Luiza Terranova; Phone Number: +55 11 5090-8421; Email: luiza.terranova@eurofarma.com

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
No Intervention: Control area
Experimental: EF192B; Application of the EF192B	Device: EF192B; EF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the effect of EF192B on the curative effect in the protection of small skin lesions through the formation of a barrier, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the EF192B in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.		12 hours
Evaluate the efficacy of EF192B barrier formation through the range of transepidermal water loss 3 minutes, 6 hours, and 24 hours after its administration	Evaluation of barrier formation through transepidermal water loss range 3 (±1) minutes, 6 hours (± 10 minutes), and 24 hours (± 30 minutes) after the end of tape stripping versus the measurement obtained immediately after tape stripping (TEWL0)	24 hours
Evaluate the efficacy of EF192B barrier formation through the range of corneometry 3 minutes, 6 hours, 12 hours, and 24 hours after its administration	Evaluation of barrier formation through corneometry range 3 (± 1) minutes, 6 hours (± 10 minutes), 12 hours (± 20 minutes), and 24 hours (± 30 minutes) after the end of tape stripping versus the measurement obtained immediately after tape stripping	24 hours
Evaluate EF192B 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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2025
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: effectiveness; Contact test
• Other Study ID Numbers: EF192B

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