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Evaluation of the EF192B Protection Versus No Treatment

NCT ID: NCT06752460

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Skin Lesions Skin Care

Keywords

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effectiveness Contact test

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EF192B

Application of the EF192B

Group Type EXPERIMENTAL

EF192B

Intervention Type DEVICE

EF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours.

Control area

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EF192B

EF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eurofarma Laboratórios S.A

Itapevi, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Gleyce Lima

Role: CONTACT

Phone: +55 11 5090-8411

Email: [email protected]

Luiza Terranova

Role: CONTACT

Phone: +55 11 5090-8421

Email: [email protected]

Facility Contacts

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Gleyce Lima

Role: primary

Luiza Terranova

Role: backup

Other Identifiers

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EF192B

Identifier Type: -

Identifier Source: org_study_id