RhytidesNCT04994990
Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles
A study testing OnabotulinumtoxinA Standard Dose and OnabotulinumtoxinA Half Standard Dose in people with Rhytides, run by Northwell Health.
Trial summary
This research is being done to determine if lower doses of botox than what is currently recommended can give similar results to patients, at lower cost and lower risk to them. Subjects will receive botox in the same areas of the upper face with standard doses on one side of the face. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhytides
- What is being tested?
- OnabotulinumtoxinA Standard Dose and OnabotulinumtoxinA Half Standard Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2023to 30 May 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-65
- In good general health as evidenced by medical history and exhibiting upper facial wrinkles on physical examination
- Agreement to adhere to Lifestyle Considerations (see section 5.3) as appropriate throughout study duration
Who cannot join
- Current use of aminoglycosides, curare like agents, and muscle relaxants
- Pregnancy or lactation
- Known allergic reactions to components of the botox formulation and any of its ingredients
- Treatment with another botox product for the face within 4 months
- Infections/preexisting weakness at the proposed injection sites on physical examination
- History of neuromuscular disorder, pre existing severe cardiovascular disease, compromised respiratory function, severe dysphagia
- Pediatric population, patients older than 65 since the effect of botox in terms of duration and magnitude is highly variable in these age groups.
About this study
This research is being done to determine if lower doses of botox than what is currently recommended can give similar results to patients, at lower cost and lower risk to them. Subjects will receive botox in the same areas of the upper face with standard doses on one side of the face. On the other side, double the botox concentration will be administered, free of charge to the participant, in order to see if the difference in concentration creates a difference in wrinkle reduction and participant satisfaction over time.
- Conditions
- Rhytides
- Being tested
- OnabotulinumtoxinA Standard Dose, OnabotulinumtoxinA Half Standard Dose
- Keywords
- Botox, Facial Wrinkles, OnabotulinumtoxinA, Cosmetic, Dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA Standard DoseDrug
Active comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA
OnabotulinumtoxinA Half Standard DoseDrug
Experimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA
| Study group | Role | What they receive |
|---|---|---|
| Standard Dosing Group | Active comparator | Not described Receives: Drug: OnabotulinumtoxinA Standard Dose |
| Half Standard Dosing Group | Experimental | Not described Receives: Drug: OnabotulinumtoxinA Half Standard Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Face Wrinkle Severity 1 Week After Botox Administration
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Measured: 4 Months
Upper Face Wrinkle Severity 1 Month After Botox Administration
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Measured: 4 Months
Upper Face Wrinkle Severity 2 Months After Botox Administration
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Measured: 4 Months
Upper Face Wrinkle Severity 3 Months After Botox Administration
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Measured: 4 Months
Upper Face Wrinkle Severity 4 Months After Botox Administration
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Measured: 4 Months
Patient Satisfaction 1 Week After Botox Administration
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Measured: 4 Months
Patient Satisfaction 1 Month After Botox Administration
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Measured: 4 Months
Patient Satisfaction 2 Months After Botox Administration
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Measured: 4 Months
Patient Satisfaction 3 Months After Botox Administration
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Measured: 4 Months
Patient Satisfaction 4 Months After Botox Administration
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start25 May 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 May 2025 (estimated)
Why it stopped: staff not available to support study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidesStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Bastidas, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994990
- Sponsor's protocol ID
- 23-0015-NH
- Status last verified
- Oct 2023
- First submitted
- 3 Aug 2021
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles
- ClinicalTrials.gov ID
- NCT04994990
- Acronym / sponsor ID
- 23-0015-NH
- Conditions
- Rhytides
- Keywords
- Botox, Facial Wrinkles, OnabotulinumtoxinA, Cosmetic, Dosage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: staff not available to support study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 6 Aug 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 research is being done to determine if lower doses of botox than what is currently recommended can give similar results to patients, at lower cost and lower risk to them. Subjects will receive botox in the same areas of the upper face with standard doses on one side of the face. On the other side, double the botox concentration will be administered, free of charge to the participant, in order to see if the difference in concentration creates a difference in wrinkle reduction and participant satisfaction over time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dosing Group | Active comparator | Drug: OnabotulinumtoxinA Standard Dose |
| Half Standard Dosing Group | Experimental | Drug: OnabotulinumtoxinA Half Standard Dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-65
- In good general health as evidenced by medical history and exhibiting upper facial wrinkles on physical examination
- Agreement to adhere to Lifestyle Considerations (see section 5.3) as appropriate throughout study duration
Key exclusion criteria (7 listed)
- Current use of aminoglycosides, curare like agents, and muscle relaxants
- Pregnancy or lactation
- Known allergic reactions to components of the botox formulation and any of its ingredients
- Treatment with another botox product for the face within 4 months
- Infections/preexisting weakness at the proposed injection sites on physical examination
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 |
|---|---|---|
| OnabotulinumtoxinA Standard DoseActive comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA | Drug | Standard Dosing Group |
| OnabotulinumtoxinA Half Standard DoseExperimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA | Drug | Half Standard Dosing Group |
Primary outcome
Upper Face Wrinkle Severity 1 Week After Botox Administration
Time frame: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Upper Face Wrinkle Severity 1 Month After Botox Administration
Time frame: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Upper Face Wrinkle Severity 2 Months After Botox Administration
Time frame: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Upper Face Wrinkle Severity 3 Months After Botox Administration
Time frame: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Upper Face Wrinkle Severity 4 Months After Botox Administration
Time frame: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Patient Satisfaction 1 Week After Botox Administration
Time frame: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Patient Satisfaction 1 Month After Botox Administration
Time frame: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Patient Satisfaction 2 Months After Botox Administration
Time frame: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Patient Satisfaction 3 Months After Botox Administration
Time frame: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Patient Satisfaction 4 Months After Botox Administration
Time frame: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Rhytides
Active, not recruiting
Hyaluronic Acid Crosslinking Clinical Study
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Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
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Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch
Parotid Gland Tumor, Facial and Neck Rhytides
Recruiting
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Photodamaged Skin, Rhytids
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
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.
Nicholas Bastidas, MD principal investigator
Northwell Health
Questions about this trial
What is this clinical trial studying?
A study testing OnabotulinumtoxinA Standard Dose and OnabotulinumtoxinA Half Standard Dose in people with Rhytides, run by Northwell Health.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Upper Face Wrinkle Severity 1 Week After Botox Administration (time frame: 4 Months). The study lists 10 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 16 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.