A Phase 4 interventional study of Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug) in Photoaging, Wrinkle and Sun Damaged Skin, sponsored by Vitality Institute Medical Products. Completed at 1 site in United States. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Vitality Institute Medical Products · Phase 4, Interventional, and Treatment
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.
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.
This is the only study on the registry with Vitality Institute Medical Products as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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)
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
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
Time frame: Day 7 (+/- 3)
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.
Time frame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
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.
Time frame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
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.
Time frame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
Plan to share: Undecided
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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