PhotoagingPhase 4NCT05162300
Same-Day Combination of VI Peel and Botox for Correction of Sun Damage, Fine Lines and Wrinkles
A Phase 4 study testing Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug) in people with Photoaging and Wrinkle, run by Vitality Institute Medical Products at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Photoaging, Wrinkle, Sun Damaged Skin
- What is being tested?
- Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2021to 1 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 15Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Wendy E. Roberts, MD
Rancho Mirage, California, 92270
About this study
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
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.
Read the 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.
- Conditions
- Photoaging, Wrinkle, Sun Damaged Skin
- Being tested
- Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)
- Keywords
- Botox, VI Peel, Wrinkles, Sun Damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)Combination product
Also called Botox, VI Peel, Neurotoxin, Chemical Peel
Same-Day combination of VI Peel applied to the full face, followed by Botox injection per label to the face.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7 (+/- 3)
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start8 Dec 2021
- Primary completion13 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitality Institute Medical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wendy E Roberts, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162300
- Sponsor's protocol ID
- 21-VITA-101
- Status last verified
- Apr 2022
- First submitted
- 18 Nov 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05162300
- Acronym / sponsor ID
- 21-VITA-101
- Conditions
- Photoaging, Wrinkle, Sun Damaged Skin
- Keywords
- Botox, VI Peel, Wrinkles, Sun Damage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vitality Institute Medical ProductsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Combination Product: Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)Also: Botox, VI Peel, Neurotoxin, Chemical PeelSame-Day combination of VI Peel applied to the full face, followed by Botox injection per label to the face. | Combination product | Group A |
Primary outcome
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
3 secondary outcomes
Change to Facial Wrinkle Severity
Time frame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
Change to Uniformity of Pigment
Time frame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
Change to
Time frame: Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- MedlinePlus: Botox Cosmetic OverviewLink provided by the sponsor.
- U.S. FDA ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy E Roberts, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug) in people with Photoaging and Wrinkle, run by Vitality Institute Medical Products at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Day 7 (+/- 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.