Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles

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 Overview

• Status: Withdrawn
• Conditions: Rhytides
• Intervention / Treatment: Drug: OnabotulinumtoxinA Standard Dose; Drug: OnabotulinumtoxinA Half Standard Dose

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas Bastidas, MD; Phone Number: 516 497 7900; Email: Nbastidas@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Dosing Group	Drug: OnabotulinumtoxinA Standard Dose; Active comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA
Experimental: Half Standard Dosing Group	Drug: OnabotulinumtoxinA Half Standard Dose; Experimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Nicholas Bastidas, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cosmetic; OnabotulinumtoxinA; Botox; Facial Wrinkles; Dosage
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 23-0015-NH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No