NCT05162300

Same-Day Combination of VI Peel and Botox for Correction of Sun Damage, Fine Lines and Wrinkles

An Open Label Cosmetic Study to Evaluate the Safety and Efficacy of the Same-day Treatment of VI Peel® and Botox® for the Correction of Sun Damage, Fine Lines, and Wrinkles on the Face

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Vitality Institute Medical Products · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to improve standards of care in the cosmetic treatment of sun damage, fine lines, and wrinkles. VI Peels® and Botox® have been used cosmetically to improve patient concerns as monotherapies. This study seeks to confirm that the same-day combination creates no additional side-effects and furthermore that patient satisfaction is heightened as a result.

Detailed description

This study seeks to utilize the mechanisms of action of both products to simultaneously address fine lines and wrinkles. VI Peels contain a synergistic blend of acids that produce keratolytic and kerato-coagulation qualities focused on desquamation and cellular renewal. The VI Peel blend contains Trichloroacetic Acid, Phenol, Salicylic Acid, Retinoic Acid and Ascorbic Acid. Botox containing Botulinum toxin type A is a purified substance, derived from a bacterium that block muscular nerve signals temporarily preventing the muscular contraction and subsequent wrinkle formation. The expected benefit of this investigational combination include improvements to Standards of Care in relation to treatment of the cosmetic patient by establishing safety of the combination treatment, improving patient outcomes by simultaneously addressing sun damage, fine lines, and wrinkles through dual mechanisms, and overall improvement to patient satisfaction.

Conditions

• Photoaging
• Wrinkle
• Sun Damaged Skin

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)	Same-Day combination of VI Peel applied to the full face, followed by Botox injection per label to the face.

Timeline

• Start date: 2021-12-08
• Primary completion: 2022-01-13
• Completion: 2022-02-01
• First posted: 2021-12-17
• Last updated: 2022-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study