Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was designed with the objective of evaluating the protection potential provided by the experimental product (Liquid Bandage) by evaluating its barrier formation capacity. Once the product's ability to form a barrier is confirmed, its ability to protect against small skin injuries, such as small cuts and bruises, blisters and cracks, is confirmed. The barrier formation also guarantees protection against the formation of calluses.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid bandage | Experimental | The liquid bandage will be applied after the tape strriping procedure and will be reapplied after 12 hours. |
|
| Control area | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid bandage | Device | Liquid elastic collodion- and benzethonium chloride-based topical solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration. | Evaluation of barrier formation through transepidermal water loss range 12 hours (± 20 minutes) after the end of tape stripping (TEWL12h) versus the measurement obtained immediately after tape stripping (TEWL0). | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 3 minutes after its administration | Evaluation of barrier formation through transepidermal water loss range 3 (±1) minutes after the end of tape stripping (TEWL3min) versus the measurement obtained immediately after tape stripping (TEWL0) | 3 minutes |
Not provided
Inclusion criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofarma Laboratorios S.A | São Paulo | 06696-000 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 6 hours after its administration. | Evaluation of barrier formation through transepidermal water loss range 6 hours (± 10 minutes) after the end of tape stripping (TEWL6h) versus the measurement obtained immediately after tape stripping (TEWL0) | 6 hours |
| Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 24 hours after its administration | Evaluation of barrier formation through transepidermal water loss range 24 hours (± 30 minutes) after the end of tape stripping (TEWL6h) versus the measurement obtained immediately after tape stripping (TEWL0) | 24 hours |
| Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 3 minutes after its administration | Evaluation of barrier formation through corneometry range 3 (± 1) minutes after the end of tape stripping (CM3min) versus the measurement obtained immediately after tape stripping (CM0) | 3 minutes |
| Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 6 hours after its administration | Evaluation of barrier formation through corneometry range 6 hours (± 10 minutes) after the end of tape stripping (CM6h) versus the measurement obtained immediately after tape stripping (CM0) | 6 hours |
| Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 12 hours after its administration | Evaluation of barrier formation through corneometry range 12 hours (± 20 minutes) after the end of tape stripping (CM12h) versus the measurement obtained immediately after tape stripping (CM0) | 12 hours |
| Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 24 hours after its administration | Evaluation of barrier formation through corneometry range 24 hours (± 30 minutes) after the end of tape stripping (CM24h) versus the measurement obtained immediately after tape stripping (CM0) | 24 hours |
| Evaluate the investigational product 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 | 12 hours |