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

NCT05162300 | Completed Phase 4 FDA Drug

• 1 other identifier: 21-VITA-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaging; Wrinkle; Sun Damaged Skin

Keywords

Botox; VI Peel; Wrinkles; Sun Damage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change to Facial Wrinkle Severity

  Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention

• Change to Uniformity of Pigment

  Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention

• Change to

  Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention

Study Arms (1)

Group A

EXPERIMENTAL

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)

Interventions

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

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

Also known as: Botox, VI Peel, Neurotoxin, Chemical Peel

Group A

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Is pregnant or lactating
• Has an active infection on their face (excluding acne)
• Has used Isotretinoin (Accutane) within the last six months
• Has had chemotherapy or radiation treatments within the last six months
• Has a history of neuromuscular disorders
• Has a history of bleeding disorders
• Has an allergy to albumin
• Has an allergy to Aspirin
• Has an allergy to Phenol
• 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
• 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
• Is unable to understand the protocol or to give informed consent
• Not willing to comply with all study requirements including return visits and photographs (eyes censored or uncensored)
• Has been diagnosed or is displaying COVID-19 symptoms -

Sponsors & Collaborators

• Vitality Institute Medical Products: lead

Study Sites (1)

Dr. Wendy E. Roberts, MD

Rancho Mirage, California, 92270, United States

Location

Related Links

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

MeSH Terms

Interventions

Botulinum Toxins; Pharmaceutical Preparations; Botulinum Toxins, Type A; Tooth Exfoliation; Neurotoxins; Chemexfoliation

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Noxae; Toxic Actions; Chemical Actions and Uses; Cosmetic Techniques; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Wendy E Roberts, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 17, 2021
• Study Start: December 8, 2021
• Primary Completion: January 13, 2022
• Study Completion: February 1, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

US (1)