NCT05089851

Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines

A Randomized, Multicenter, Double-blinded, Placebo Controlled, Split-Face Study Evaluating Procedure Pairing of a Peptide Anti-Aging Serum With Onabotulinumtoxin A in the Treatment of Periorbital Facial Wrinkles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Revision Skincare · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate the procedure-pairing of OnabotulinumtoxinA with a peptide anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and radiance of the face after 12 weeks of twice-daily use in female subjects ages 35 - 60 as compared to placebo. A total of 29 subjects completed study participation.

Detailed description

This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate procedure pairing of a peptide anti-aging serum with Onabotulinumtoxin A in the treatment of periorbital facial wrinkles when used over the course of 12 weeks by women with moderate to severe crow's feet wrinkles and fine lines, and mild to moderate photoaging. Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for wrinkles, fine lines, and skin appearance will be graded at rest and at maximum smile for each side. Investigator and subject tolerability, self-assessment questionnaire and VISIA photography will be completed at baseline, weeks 4, 8 and 12. A total of 29 subjects completed study participation.

Conditions

• Wrinkles
• Photoaging
• Fine Lines

Interventions

Type	Name	Description
PROCEDURE	Onabotulinumtoxin A	Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)
COMBINATION_PRODUCT	Facial Cleanser	Facial Cleanser to be used by participants twice daily
COMBINATION_PRODUCT	Facial Moisturizer	Bland moisturizer to be used by study participants after serum twice daily.
COMBINATION_PRODUCT	Sunscreen	Bland Sunscreen to be used by study participants after serum and moisturizer in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.

Timeline

• Start date: 2020-08-23
• Primary completion: 2021-06-03
• Completion: 2021-06-03
• First posted: 2021-10-22
• Last updated: 2021-10-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study