Evaluation of the EF192B Protection Versus No Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEurofarma Laboratorios S.A.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EF192B
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov