Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles

NCT ID: NCT04994990

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2025-05-30

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.

Conditions

Rhytides

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Standard Dosing Group

Group Type: ACTIVE_COMPARATOR

OnabotulinumtoxinA Standard Dose

Intervention Type: DRUG

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

Half Standard Dosing Group

Group Type: EXPERIMENTAL

OnabotulinumtoxinA Half Standard Dose

Intervention Type: DRUG

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

Interventions

OnabotulinumtoxinA Standard Dose

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

Intervention Type: DRUG

OnabotulinumtoxinA Half Standard Dose

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Bastidas, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Other Identifiers

23-0015-NH

Identifier Type: -

Identifier Source: org_study_id