Evaluation of the Protection of a Liquid Bandage

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05888311
• Other study ID #: EF 184B
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: Eurofarma Laboratorios S.A.
• Contact: Edilene Macedo
• Phone: 1150908600
• Email: edilene.macedo[@]eurofarma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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 .

Related Conditions & MeSH terms

• Skin Care

Intervention

Device:
• Liquid bandage
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.

Other:
• Activated carbon
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.

Locations

Country	Name	City	State
Brazil	Eurofarma Laboratorios S.A	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

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