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

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.

Study Overview

• Status: Completed
• Conditions: Wrinkle; Photoaging; Sun Damaged Skin
• Intervention / Treatment: Combination product: Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Rancho Mirage, California, United States, 92270
      • Dr. Wendy E. Roberts, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy Female and Males subjects of any race
2. Ages 30-70 Years old
3. Subjects who can read, understand, and sign the Informed Consent Form.
4. Subjects willing and able to comply with all study requirements, including return visits and photographs (eyes censored or uncensored).

Exclusion Criteria:

1. Is pregnant or lactating
2. Has an active infection on their face (excluding acne)
3. Has used Isotretinoin (Accutane) within the last six months
4. Has had chemotherapy or radiation treatments within the last six months
5. Has a history of neuromuscular disorders
6. Has a history of bleeding disorders
7. Has an allergy to albumin
8. Has an allergy to Aspirin
9. Has an allergy to Phenol

10. Has received the following treatments in the last 6 months:

    botulinum toxin, soft tissue filler, medium to deep chemical peel, ablative laser, radio frequency treatment, ultrasound device treatment, non-ablative laser treatment

11. Is planning on receiving in the next 1months: soft tissue filler, medium to deep chemical peel, ablative laser, radio frequency treatment, ultrasound device treatment, nonablative laser treatment
12. Is unable to understand the protocol or to give informed consent
13. Not willing to comply with all study requirements including return visits and photographs (eyes censored or uncensored)
14. Has been diagnosed or is displaying COVID-19 symptoms -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Group A; Subjects will be given the same-day combination of VI Peel (Procedure) and Botox Cosmetic (Botulinum Toxin) (Drug). Botox will be administered via intramuscular injection via package insert to Glabella, Forehead and Crows Feet. Dosage will follow package insert guidelines. The two interventions will be administered once at the start of the study, subsequent study visits will focus on assessment and evaluation.

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.; Other Names: Botox; Neurotoxin; VI Peel; Chemical Peel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	To establish safety of the same-day combination of VI Peel & Botox, the study will measure the rate and occurrence of Adverse Events as compared to a stand-alone treatment of Botox. Rate and occurrence of Botox as a stand-alone intervention will be based off of the package insert indicating each Adverse Event	Day 7 (+/- 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change to Facial Wrinkle Severity	Overall improvements to fine lines and wrinkles will be measured using the Facial Wrinkle Severity Scale described below. Facial Wrinkle Severity Scale (FWSS) Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles. Principal investigator will rate and measure subject on enrollment into the study, will grade again at Day 7 (+ / - 3) and again at Day 30.	Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
Change to Uniformity of Pigment	Overall improvements to pigment will be measured using the Uniformity of Pigment Scale described below. Uniformity of Pigment; Grade 0 = Uniform, Grade 1 = mild, Grade 2 = moderate, Grade 3 = moderate to severe, Grade 4 = Severely Ununiform. Principal investigator will rate and measure subject on enrollment into the study, will grade again at Day 7 (+ / - 3) and again at Day 30.	Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
Change to	Overall improvements to Skin Tone will be measured via the Skin Tone grading scale below. Skin Tone; Grade 0 = Clear and Radiant, Grade 1 = Mild Irregularities, Grade 2 = Moderate Irregularities, Grade 3 = Moderate to Severe Irregularities, Grade 4 = Severe Irregularities, ie. Sallow, Dull. Principal investigator will rate and measure subject on enrollment into the study, will grade again at Day 7 (+ / - 3) and again at Day 30.	Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention

Collaborators and Investigators

• Sponsor: Vitality Institute Medical Products
• Investigators: Principal Investigator: Wendy E Roberts, MD, Principal Investigator

Publications and helpful links

Helpful Links

• U.S. FDA Resources
• MedlinePlus: Botox Cosmetic Overview

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2021
• Primary Completion (ACTUAL): January 13, 2022
• Study Completion (ACTUAL): February 1, 2022

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (ACTUAL): December 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Botox; Wrinkles; Sun Damage; VI Peel
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 21-VITA-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes