NCT06633731

Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Revision Skincare · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. Eleven (11) healthy female subjects completed the clinical study.

Detailed description

This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial radiance, skin smoothness, and overall appearance was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Conditions

• Skin Smoothness
• Radiance
• Overall Appearance

Interventions

Type	Name	Description
OTHER	Biocellulose Mask	Immediately after treatment, a Biocellulose Mask was applied to the subjects global face for 8 to 10 minutes.
OTHER	Post Procedure Cream	Immediately after treatment and after Biocellulose Mask removal, the Post-Procedure Cream was applied to the subjects global face. Subjects were instructed to apply to the global face from days 1 - 3 post treatment.
OTHER	Gentle Cleanser	Subjects were instructed to wash their face with the Gentle Foaming Cleanser twice daily for 12 weeks.
OTHER	Facial Moisturizer	Subjects were instructed to apply the facial moisturizer twice daily to the global face from day 3 after treatment until next study visit.
OTHER	sunscreen	Subjects were instructed to apply the bland sunscreen to the global face once daily in the morning, with re-application with extended sun exposure per FDA guidelines.

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-03-19
• Completion: 2024-03-19
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: United States