NCT04994990

Brief 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. 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2023

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 25, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

August 3, 2021

Last Update Submit

October 13, 2023

Conditions

Rhytides

Keywords

BotoxFacial WrinklesOnabotulinumtoxinACosmeticDosage

Outcome Measures

Primary Outcomes (10)

  • 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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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

    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

    4 Months

Study Arms (2)

Standard Dosing Group

ACTIVE COMPARATOR
Drug: OnabotulinumtoxinA Standard Dose

Half Standard Dosing Group

EXPERIMENTAL
Drug: OnabotulinumtoxinA Half Standard Dose

Interventions

OnabotulinumtoxinA Standard DoseDRUG

Active comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA

Standard Dosing Group
OnabotulinumtoxinA Half Standard DoseDRUG

Experimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA

Half Standard Dosing Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Nicholas Bastidas, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 6, 2021

Study Start

May 25, 2023

Primary Completion

November 30, 2024

Study Completion

May 30, 2025

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share