Randomized, Open Clinical Study to Evaluate the Protective Potential of a Liquid Bandage Based on Liquid Elastic Collodion Versus no Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Care
- Sponsor
- Eurofarma Laboratorios S.A.
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Time Frame: 12 hours
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).
Secondary Outcomes
- Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 3 minutes after its administration(3 minutes)
- Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 6 hours after its administration.(6 hours)
- Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 24 hours after its administration(24 hours)
- Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 3 minutes after its administration(3 minutes)
- Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 6 hours after its administration(6 hours)
- Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 12 hours after its administration(12 hours)
- Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 24 hours after its administration(24 hours)
- Evaluate the investigational product water resistance after four washes(12 hours)