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

NCT ID: NCT05162300

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-08
• Study Completion Date: 2022-02-01

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.

Conditions

Photoaging; Wrinkle; Sun Damaged Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)

Intervention Type: COMBINATION_PRODUCT

Same-Day combination of VI Peel applied to the full face, followed by Botox injection per label to the face.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Botox; VI Peel; Neurotoxin; Chemical Peel

Eligibility Criteria

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 -

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vitality Institute Medical Products

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy E Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Dr. Wendy E. Roberts, MD

Rancho Mirage, California, United States

Countries

United States

Related Links

https://medlineplus.gov/botox.html

MedlinePlus: Botox Cosmetic Overview

https://clinicaltrials.gov/ct2/info/fdalinks

U.S. FDA Resources

Other Identifiers

21-VITA-101

Identifier Type: -

Identifier Source: org_study_id