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.
Condition or disease
Skin Lesions
Skin Care
Intervention/treatment
EF192B
| Study Type : |
INTERVENTIONAL |
| Estimated Enrollment : |
72 participants |
| Masking : |
NONE |
| Primary Purpose : |
TREATMENT |
| Official Title : |
Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment |
| Actual Study Start Date : |
2025-08-31 |
| Estimated Primary Completion Date : |
2025-10-31 |
| Estimated Study Completion Date : |
2025-10-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: |
18 Years
to 70 Years
|
| Sexes Eligible for Study: |
ALL |
| Accepts Healthy Volunteers: |
1 |
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.