Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05162300
Other study ID # 21-VITA-101
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 8, 2021
Est. completion date February 1, 2022

Study information

Verified date April 2022
Source Vitality Institute Medical Products
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 1, 2022
Est. primary completion date January 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Dr. Wendy E. Roberts, MD Rancho Mirage California

Sponsors (1)

Lead Sponsor Collaborator
Vitality Institute Medical Products

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT05098912 - Comparing Polydioxanone Thread Embedding Acupuncture and Manual Acupuncture for Nasolabial Fold Reduction N/A
Completed NCT05271136 - A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum N/A
Completed NCT05096247 - Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device N/A
Completed NCT05097157 - Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions N/A
Completed NCT04128046 - The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation N/A
Active, not recruiting NCT04727099 - Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™ N/A
Active, not recruiting NCT06140628 - A 28-day Clinical Study on Facial Skin Rejuvenation N/A
Not yet recruiting NCT05524779 - BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Facial Improvement N/A
Completed NCT05514782 - A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum N/A
Completed NCT06123572 - A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel N/A
Completed NCT04911374 - An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream N/A
Recruiting NCT04989361 - Soluble Hyaluronic Acid Microneedle VS. Non-ablative Fractional Laser on Infraorbital Wrinkles. N/A
Recruiting NCT04540900 - A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions Phase 1
Recruiting NCT06202274 - Clinical Study to Evaluate the Safety and Efficacy of Candela Technology N/A
Recruiting NCT06074276 - The Effects of Almond on Facial Skin Collagen and Wrinkles N/A
Completed NCT06366503 - Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation N/A
Active, not recruiting NCT06219278 - A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles N/A
Active, not recruiting NCT06192550 - Functional Usability and Feasibility Testing of the Profound Matrix™ System N/A
Completed NCT04650620 - Study to Evaluate the Performance and Safety of the Medical Device Plenhyage® N/A
Completed NCT03729700 - The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome N/A