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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
EF192B
DeviceEF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: EF192BExperimental treatment 1 intervention
Group B: Control areaNo intervention 0 interventions
Trial outcomes
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 hoursSecondary 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 hours2
Evaluate the efficacy of EF192B barrier formation through the range of transepidermal water loss 3 minutes, 6 hours, and 24 hours after its administration
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)
Time frame
24 hours3
Evaluate the efficacy of EF192B barrier formation through the range of corneometry 3 minutes, 6 hours, 12 hours, and 24 hours after its administration
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
Time frame
24 hours4
Evaluate EF192B water resistance after four washes
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
Time frame
12 hoursSponsors and contacts
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Source ClinicalTrials.gov
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