Evaluation of the EF192B Protection Versus No Treatment | NCT06752460

Studies
Evaluation of the EF192B Protection Versus No Treatment

NCT06752460

Sponsor

Eurofarma Laboratorios S.A.

Status

Not yet recruiting

Last Update Posted

Dec 30, 2024Actual

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Skin Lesions
Skin Care

Interventions

EF192B

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2025Estimated

Primary Completion Date

Oct 31, 2025Estimated

Completion Date

Oct 31, 2025Estimated

First Submitted Date

Dec 11, 2024

First Submission Date that Met QC Criteria

Dec 20, 2024

First Posted Date

Dec 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2024

Last Update Posted Date

Dec 30, 2024Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Label	Type	Description	Intervention Names
EF192B	Experimental	Application of the EF192B	Device: EF192B
Control area	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
EF192B	Device	EF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours.	EF192B

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Gleyce Lima	Contact	+55 11 5090-8411		gleyce.lima@eurofarma.com
Luiza Terranova	Contact	+55 11 5090-8421		luiza.terranova@eurofarma.com