WrinklesNCT05089851
Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines
A study testing Onabotulinumtoxin A, Facial Cleanser and Facial Moisturizer in people with Wrinkles and Photoaging, run by Revision Skincare at 3 sites in United States.
Trial summary
This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate the procedure-pairing of OnabotulinumtoxinA with a peptide anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and radiance of the face after 12 weeks of twice-daily… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles, Photoaging, Fine Lines
- What is being tested?
- Onabotulinumtoxin A, Facial Cleanser and Facial Moisturizer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Aug 2020to 3 Jun 2021
- Phase
- Interventional
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects must be between 35-60 years of age.
- Female subjects of childbearing potential must be willing to use a form of birth control during the study.
- Subjects with Fitzpatrick I-VI photo skin type.
- Subjects must have moderate to severe crow's feet facial wrinkles (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
- Subjects must have moderate to severe crow's feet fine lines (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
- Subjects may have mild to moderate photo-aging (score 3-6 on 0-9 scale) secondary to physiologic aging, hormonal influences, and environmental stressors.
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- Subjects must have no skin disease in the facial area being evaluated.
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be willing to provide verbal understanding and written informed consent
Who cannot join
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the Investigator.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Juvly Aesthetics
Columbus, Ohio, 43215
Infinity Skin Care
Coralville, Iowa, 52241
Shino Bay Cosmetic Dermatology and Laser Institute
Fort Lauderdale, Florida, 33301
About this study
Official title: A Randomized, Multicenter, Double-blinded, Placebo Controlled, Split-Face Study Evaluating Procedure Pairing of a Peptide Anti-Aging Serum With Onabotulinumtoxin A in the Treatment of Periorbital Facial Wrinkles
This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate the procedure-pairing of OnabotulinumtoxinA with a peptide anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and radiance of the face after 12 weeks of twice-daily use in female subjects ages 35 - 60 as compared to placebo. A total of 29 subjects completed study participation.
Read the detailed description
This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate procedure pairing of a peptide anti-aging serum with Onabotulinumtoxin A in the treatment of periorbital facial wrinkles when used over the course of 12 weeks by women with moderate to severe crow's feet wrinkles and fine lines, and mild to moderate photoaging.
Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for wrinkles, fine lines, and skin appearance will be graded at rest and at maximum smile for each side. Investigator and subject tolerability, self-assessment questionnaire and VISIA photography will be completed at baseline, weeks 4, 8 and 12.
A total of 29 subjects completed study participation.
- Conditions
- Wrinkles, Photoaging, Fine Lines
- Being tested
- Onabotulinumtoxin A, Facial Cleanser, Facial Moisturizer, Sunscreen
- Keywords
- anti-aging, serum, onabotulinum toxin A, Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onabotulinumtoxin AProcedure or surgery
Also called Botulinum Toxin, Allergan
Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)
Facial CleanserCombination product
Facial Cleanser to be used by participants twice daily
Facial MoisturizerCombination product
Bland moisturizer to be used by study participants after serum twice daily.
SunscreenCombination product
Also called Aveeno Face Milk SPF 40+
Bland Sunscreen to be used by study participants after serum and moisturizer in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.
| Study group | Role | What they receive |
|---|---|---|
| Peptide Antiaging Serum | Active comparator | Dosage Form: Serum composed of water, thickener, and bioactive ingredients including peptides and antioxidants.
Frequency of Dosage: Twice daily. Subjects will be asked to pump 1x and apply to assigned facial side (left or right) corresponding to randomization.
Study Duration: 12 weeks Receives: Procedure: Onabotulinumtoxin A; Combination Product: Facial Cleanser; Combination Product: Facial Moisturizer; Combination Product: Sunscreen |
| Placebo Serum | Placebo comparator | Dosage Form: Serum composed of water and thickener
Frequency of Dosage: Twice daily. Subjects will be asked to pump 1x and apply to assigned facial side (left or right) corresponding to randomization.
Study Duration: 12 weeks Receives: Procedure: Onabotulinumtoxin A; Combination Product: Facial Cleanser; Combination Product: Facial Moisturizer; Combination Product: Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy Grading by Griffith's Scale
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10 point scale. A change in scores at Day 28, Day 56, and Day 84 (+/- 3 days) in comparison to baseline indicates an improvement for the indicated parameter.
The efficacy parameters will be assessed at rest and at maximum smile and at specific areas on both the left and right sides of the subjects face using a modified Griffith's 10 point scale according to the following numerical definitions (half point scores may be used as necessary to more accurately describe skin conditions)
0 = None (best possible condition)
1 to 3 = Mild 4 to 6 = Moderate 7 to 9 = Severe (worst possible condition). The lower the score equates to the best possible outcome.
Measured: 12 weeks
Tolerability Scores
The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in scores or lack of significant change at Day 28, Day 56, and Day 84 in comparison to baseline indicates tolerability / safety of the test material. Four point scale with a lower score indicating a better outcome.
0 = None
- = Mild
- = Moderate
- = Severe
Measured: 12 weeks
Incidence of Adverse Events
The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediate post-procedure and through-out the length of the study.
Measured: 12 weeks
Secondary outcomes (2)
Self-Assessment Questionnaire
The secondary efficacy endpoint will be the Self-Assessment Questionnaire. A change in response values at Day 28, Day 56, and Day 84 indicates and improvement compared to baseline response values. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.
Measured: 12 weeks
Secondary Tolerability Scores
The secondary tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in scores or lack of significant change at Day 28, Day 56, Day 84, and Day 168 in comparison to baseline indicates tolerability / safety of the test material. Four point scale with a lower score indicating a better outcome.
0 = None
- = Mild
- = Moderate
- = Severe
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start23 Aug 2020
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Split-Face
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089851
- Sponsor's protocol ID
- RS-2020-01
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blinded, Placebo Controlled, Split-Face Study Evaluating Procedure Pairing of a Peptide Anti-Aging Serum With Onabotulinumtoxin A in the Treatment of Periorbital Facial Wrinkles
- ClinicalTrials.gov ID
- NCT05089851
- Acronym / sponsor ID
- RS-2020-01
- Conditions
- Wrinkles, Photoaging, Fine Lines
- Keywords
- anti-aging, serum, onabotulinum toxin A, Botox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2020 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 22 Oct 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 randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate the procedure-pairing of OnabotulinumtoxinA with a peptide anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and radiance of the face after 12 weeks of twice-daily use in female subjects ages 35 - 60 as compared to placebo. A total of 29 subjects completed study participation.
Detailed description
This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate procedure pairing of a peptide anti-aging serum with Onabotulinumtoxin A in the treatment of periorbital facial wrinkles when used over the course of 12 weeks by women with moderate to severe crow's feet wrinkles and fine lines, and mild to moderate photoaging.
Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for wrinkles, fine lines, and skin appearance will be graded at rest and at maximum smile for each side. Investigator and subject tolerability, self-assessment questionnaire and VISIA photography will be completed at baseline, weeks 4, 8 and 12.
A total of 29 subjects completed study participation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Split-Face
| Arm | Type | Receives |
|---|---|---|
| Peptide Antiaging Serum | Active comparator | Procedure: Onabotulinumtoxin A, Combination Product: Facial Cleanser, Combination Product: Facial Moisturizer, Combination Product: SunscreenDosage Form: Serum composed of water, thickener, and bioactive ingredients including peptides and antioxidants. Frequency of Dosage: Twice daily. Subjects will be asked to pump 1x and apply to assigned facial side (left or right) corresponding to randomization. Study Duration: 12 weeks |
| Placebo Serum | Placebo comparator | Procedure: Onabotulinumtoxin A, Combination Product: Facial Cleanser, Combination Product: Facial Moisturizer, Combination Product: SunscreenDosage Form: Serum composed of water and thickener Frequency of Dosage: Twice daily. Subjects will be asked to pump 1x and apply to assigned facial side (left or right) corresponding to randomization. Study Duration: 12 weeks |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Female subjects must be between 35-60 years of age.
- Female subjects of childbearing potential must be willing to use a form of birth control during the study.
- Subjects with Fitzpatrick I-VI photo skin type.
- Subjects must have moderate to severe crow's feet facial wrinkles (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
- Subjects must have moderate to severe crow's feet fine lines (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
Key exclusion criteria (4 listed)
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the Investigator.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
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 |
|---|---|---|
| Onabotulinumtoxin AAlso: Botulinum Toxin, AllerganSubjects will receive 20 - 24 units to the crows feet (10 - 12 units per side) | Procedure or surgery | Peptide Antiaging Serum, Placebo Serum |
| Facial CleanserFacial Cleanser to be used by participants twice daily | Combination product | Peptide Antiaging Serum, Placebo Serum |
| Facial MoisturizerBland moisturizer to be used by study participants after serum twice daily. | Combination product | Peptide Antiaging Serum, Placebo Serum |
| SunscreenAlso: Aveeno Face Milk SPF 40+Bland Sunscreen to be used by study participants after serum and moisturizer in the morning. Sunscreen to be reapplied if continuous sun exposure occurs. | Combination product | Peptide Antiaging Serum, Placebo Serum |
Primary outcome
Clinical Efficacy Grading by Griffith's Scale
Time frame: 12 weeks
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10 point scale. A change in scores at Day 28, Day 56, and Day 84 (+/- 3 days) in comparison to baseline indicates an improvement for the indicated parameter. The efficacy parameters will be assessed at rest and at maximum smile and at specific areas on both the left and right sides of the subjects face using a modified Griffith's 10 point scale according to the following numerical definitions (half point scores may be used as necessary to more accurately describe skin conditions) 0 = None (best possible condition) 1 to 3 = Mild 4 to 6 = Moderate 7 to 9 = Severe (worst possible condition). The lower the score equates to the best possible outcome.
Tolerability Scores
Time frame: 12 weeks
The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in scores or lack of significant change at Day 28, Day 56, and Day 84 in comparison to baseline indicates tolerability / safety of the test material. Four point scale with a lower score indicating a better outcome. 0 = None 1. = Mild 2. = Moderate 3. = Severe
Incidence of Adverse Events
Time frame: 12 weeks
The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediate post-procedure and through-out the length of the study.
2 secondary outcomes
Self-Assessment Questionnaire
Time frame: 12 weeks
Secondary Tolerability Scores
Time frame: 12 weeks
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 28 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onabotulinumtoxin A, Facial Cleanser and Facial Moisturizer in people with Wrinkles and Photoaging, run by Revision Skincare at 3 sites 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 9 inclusion and 4 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Clinical Efficacy Grading by Griffith's Scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 28 Oct 2021.