Evaluation of the Protection of a Liquid Bandage

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Open Clinical Study to Evaluate the Protective Potential of a Liquid Bandage Based on Liquid Elastic Collodion Versus no Treatment

Conditions
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Skin Care

Intervention / Treatment
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* Device: Liquid bandage
* Other: Activated carbon


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age between 18 and 70 years old. 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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Visit 1, demographic data and medical history will be obtained. Visit 2, two areas will be demarcated on the participant's forearm, with activated charcoal applied to both areas. The bandage will be applied to the corresponding area, with photos captured in both the treated and control areas. After 12 hours, new photos of the areas will be taken. The bandage will be reapplied to the treated area and the occurrence of adverse events will be assessed. For the first 25 participants, two areas will also be demarcated on the contralateral forearm, with activated charcoal applied to both areas. The bandage will be applied to the corresponding area, with photos taken of both areas. 4 washes of the areas of the contralateral forearm will be carried out at intervals of 30 minutes. After each wash, new photos will be taken. Visit 3, new photos will be obtained of the treatment and control areas 24 hours after the first application of the bandage. The occurrence of adverse events will be checked.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liquid bandage<br>Will receive the application of the experimental product (liquid bandage) on the area with activated carbon at the beginning (T0) and at the end of visit 1 (T12). | Device: Liquid bandage<br>* Two areas measuring 3.0 cm x 3.0 cm will be randomly demarcated on one of your forearms, with activated carbon applied to both areas. An area to be treated with the experimental product will be determined by randomization.<br>Other: Activated carbon<br>* Two areas measuring 3.0 cm x 3.0 cm will be randomly demarcated on one of your forearms, with activated carbon applied to both areas. An untreated area (control area) will be determined by randomization.<br>|
| Other: Control area<br>will not receive the experimental product over activated carbon. | Other: Activated carbon<br>* Two areas measuring 3.0 cm x 3.0 cm will be randomly demarcated on one of your forearms, with activated carbon applied to both areas. An untreated area (control area) will be determined by randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average variation in color change in relation to the control area 12 hours after application of the experimental product. | Primary efficacy analyzes (barrier formation 12 hours after product application) will be based on the intention-to-treat population, which includes all randomized participants who have data up to at least 12 hours after product application. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average variation in color change in relation to the control area in 01 washes after applying the experimental product. | Secondary efficacy analyzes (resistance to water barrier formation up to 24 hours after product application) will be based on the per-protocol population, which include all randomized participants who present data for all study assessment times without major protocol violations. | 1 hours | 
| Average variation in color change in relation to the control area in 02 washes after applying the experimental product. | Secondary efficacy analyzes (resistance to water barrier formation up to 24 hours after product application) will be based on the per-protocol population, which include all randomized participants who present data for all study assessment times without major protocol violations. | 2 hours | 
| Average variation in color change in relation to the control area in 03 washes after applying the experimental product. | Secondary efficacy analyzes (resistance to water barrier formation up to 24 hours after product application) will be based on the per-protocol population, which include all randomized participants who present data for all study assessment times without major protocol violations. | 3 hours | 
| Average variation in color change in relation to the control area in 04 washes after applying the experimental product. | Secondary efficacy analyzes (resistance to water barrier formation up to 24 hours after product application) will be based on the per-protocol population, which include all randomized participants who present data for all study assessment times without major protocol violations. | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effectiveness, Contact test