Clinical trial NCT05162300: Same-Day Combination of VI Peel and Botox for Correction of Sun Damage, Fine Lines and Wrinkles
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Photoaging
Wrinkle
Sun Damaged Skin
Keywords: Botox
VI Peel
Wrinkles
Sun Damage
Lead sponsor: Vitality Institute Medical Products
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Day 7 (+/- 3)
Secondary outcomes:
measure: Change to Facial Wrinkle Severity
timeFrame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
measure: Change to Uniformity of Pigment
timeFrame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
measure: Change to
timeFrame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Dr. Wendy E. Roberts, MD
state: California
Study officials:
affiliation: Principal Investigator
name: Wendy E Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References: