Evaluation of the Protection of a Liquid Bandage

NCT05888311 | Completed

• 1 other identifier: EF 184B
• 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 (Liquid Bandage) by evaluating its barrier formation capacity. Once the product's ability to form a barrier is confirmed, its ability to protect against small skin injuries, such as small cuts and bruises, blisters and cracks, is confirmed. The barrier formation also guarantees protection against the formation of calluses.

Conditions

Skin Care

Keywords

effectiveness; Contact test

Outcome Measures

Primary Outcomes (1)

• Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.

  Evaluation of barrier formation through transepidermal water loss range 12 hours (± 20 minutes) after the end of tape stripping (TEWL12h) versus the measurement obtained immediately after tape stripping (TEWL0).

  12 hours

Secondary Outcomes (8)

• Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 3 minutes after its administration

  3 minutes

• Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 6 hours after its administration.

  6 hours

• Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 24 hours after its administration

  24 hours

• Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 3 minutes after its administration

  3 minutes

• Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 6 hours after its administration

  6 hours

Study Arms (2)

Liquid bandage

EXPERIMENTAL

The liquid bandage will be applied after the tape strriping procedure and will be reapplied after 12 hours.

Device: Liquid bandage

Control area

NO INTERVENTION

Interventions

Liquid bandage DEVICE

Liquid elastic collodion- and benzethonium chloride-based topical solution

Liquid bandage

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 Laboratorios S.A

São Paulo, 06696-000, Brazil

Location

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: May 4, 2023
• First Posted: June 5, 2023
• Study Start: February 18, 2025
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-02

Locations

BR (1)