NCT05272787

Clinical Trial to Evaluate Safety and Efficacy of a Facial and Lip Moisturizer in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser

A Single-Center, Open-Label, Randomized Safety-in-Use Clinical Study to Assess the Topical Tolerability and Efficacy of a Facial Moisturizer and Lip Moisturizer During and After 21±2 Days of Use in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is study aims to evaluate the topical safety (tolerability/acceptability) and efficacy of TH Facial Moisturizer and TH Lip Moisturizer Investigational products after 21 ± 2 days of use under normal conditions on the half-face by adult participants who underwent dermatological facial procedure with fractional CO2 Laser under the supervision of a dermatologist. For these investigational products, safety parameters, clinical efficacy, instrumental efficacy (skin hydration, skin barrier integrity and facial imaging) and perceived efficacy through subjective perception questionnaires will be evaluated. Subjects will receive the product to use it at home for 21 +/- 2 days.

Conditions

• Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser

Interventions

Type	Name	Description
OTHER	TH Facial Moisturizer	All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.
OTHER	TH Lip Moisturizer	All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.
OTHER	Facial Moisturizer B (Control)	All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.
OTHER	Sunscreen	Auxiliary product
OTHER	Facial wash	Auxiliary product.

Timeline

• Start date: 2022-03-10
• Primary completion: 2022-04-13
• Completion: 2022-06-16
• First posted: 2022-03-09
• Last updated: 2023-06-29

Locations

1 site across 1 country: Brazil