Skin Care Clinical Trial
Official title:
Randomized, Open Clinical Study to Evaluate the Protective Potential of a Liquid Bandage Based on Liquid Elastic Collodion Versus no Treatment
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | August 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 . |
Country | Name | City | State |
---|---|---|---|
Brazil | Eurofarma Laboratorios S.A | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Eurofarma Laboratorios S.A. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of adverse event and treatment discontinuations due to adverse event. | The safety assessment will be based on the safety population, which includes all randomized research participants who receive the first application of the investigational product and who perform at least one safety assessment after randomization | 12 hours | |
Other | Incidence of adverse event and treatment discontinuations due to adverse event. | The safety assessment will be based on the safety population, which includes all randomized research participants who receive the first application of the investigational product and who perform at least one safety assessment after randomization | 24 hours | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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