Evaluation of the EF192B Protection Versus No Treatment

Launched by EUROFARMA LABORATORIOS S.A. · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new product called EF192B, which is designed to help protect the skin. The main goal is to see how well EF192B can create a barrier on the skin, which may help prevent small injuries like cuts, bruises, blisters, and cracks. Additionally, this barrier could help stop calluses from forming. The trial is not yet recruiting participants but will focus on adults aged 18 to 70 years with certain skin types and healthy skin on their forearms.

To be eligible for the study, participants must agree to follow the study rules and attend scheduled visits. However, people with specific skin diseases, certain health conditions, or those who are pregnant or breastfeeding cannot participate. If you're interested in joining, you will need to sign consent forms and check in with the study team about your health history. Overall, this trial aims to learn more about how EF192B can offer skin protection and improve skin care.

Gender

ALL

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.