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OpenTrials
Completed

NCT Number: NCT05162300

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

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.

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Key information

Conditions

Photoaging Sun Damaged Skin Wrinkle

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Wendy E. Roberts, MD

Rancho Mirage, California, 92270, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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 -

Treatment and study plan

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.

Other names: Botox, VI Peel, Neurotoxin, Chemical Peel

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 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 outcomes

  1. Change to Facial Wrinkle Severity

    Time frame: 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.

  2. Change to Uniformity of Pigment

    Time frame: 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.

  3. Change to

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vitality Institute Medical Products

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2021
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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