Evaluation of the Protection of a Liquid Bandage
- Conditions
- Skin Care
- Interventions
- Device: Liquid bandage
- Registration Number
- NCT05888311
- Lead Sponsor
- Eurofarma Laboratorios S.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liquid bandage Liquid bandage The liquid bandage will be applied after the tape strriping procedure and will be reapplied after 12 hours.
- Primary Outcome Measures
Name Time Method Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration. 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 Outcome Measures
Name Time Method Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 3 minutes after its administration 3 minutes 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)
Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 6 hours after its administration. 6 hours 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)
Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 24 hours after its administration 24 hours 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)
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 3 minutes after its administration 3 minutes 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)
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 6 hours after its administration 6 hours 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)
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 12 hours after its administration 12 hours 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)
Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 24 hours after its administration 24 hours 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)
Evaluate the investigational product water resistance after four washes 12 hours 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
Trial Locations
- Locations (1)
Eurofarma Laboratorios S.A
🇧🇷São Paulo, Brazil