Evaluation of the EF192B Protection Versus No Treatment

NCT06752460 | Not Yet Recruiting

• 1 other identifier: EF192B
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Lesions; Skin Care

Keywords

effectiveness; Contact test

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• 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

  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

  24 hours

• Evaluate EF192B water resistance after four washes

  12 hours

Study Arms (2)

EF192B

EXPERIMENTAL

Application of the EF192B

Device: EF192B

Control area

NO INTERVENTION

Interventions

EF192B DEVICE

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

EF192B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratórios S.A

Itapevi, São Paulo, 06696-000, Brazil

Location

Central Study Contacts

Gleyce Lima

CONTACT

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

Luiza Terranova

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 30, 2024
• Study Start: August 31, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

BR (1)