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

Phase 4

Completed

• Conditions: Photoaging; Wrinkle; Sun Damaged Skin
• Interventions: Combination Product: Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)

• Registration Number: NCT05162300
• Lead Sponsor: Vitality Institute Medical Products

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-12-03
• Study Start: 2021-12-08
• Study First Posted: 2021-12-17
• Primary Completion: 2022-01-13
• Study Completion: 2022-02-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Day 7 (+/- 3)	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

Secondary Outcome Measures

Name	Time	Method
Change to Facial Wrinkle Severity	Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention	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.
Change to Uniformity of Pigment	Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention	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.
Change to	Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention	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.

Trial Locations

Locations (1)

Dr. Wendy E. Roberts, MD; 🇺🇸 Rancho Mirage, California, United States