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NCT Number: NCT06752460

Evaluation of the EF192B Protection 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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EF192B

Device

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

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.

    Time frame: 12 hours

Secondary outcomes

  1. Efficacy of the EF192B in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.

    Time frame: 12 hours

  2. Evaluate the efficacy of EF192B barrier formation through the range of transepidermal water loss 3 minutes, 6 hours, and 24 hours after its administration

    Time frame: 24 hours

    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)

  3. Evaluate the efficacy of EF192B barrier formation through the range of corneometry 3 minutes, 6 hours, 12 hours, and 24 hours after its administration

    Time frame: 24 hours

    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

  4. Evaluate EF192B water resistance after four washes

    Time frame: 12 hours

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Gleyce Lima

CONTACT

[email protected]

+55 11 5090-8411

Luiza Terranova

CONTACT

[email protected]

+55 11 5090-8421

Sponsors and collaborators

Lead sponsor

Eurofarma Laboratorios S.A.

Industry

Registry information

Official study title

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

Acronym: Spray B

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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