Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles

Rhytides Clinical Trial

Official title:

Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04994990
• Other study ID #: 23-0015-NH
• Status: Withdrawn
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhytides

Intervention

Drug:
• OnabotulinumtoxinA Standard Dose
Active comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA
• OnabotulinumtoxinA Half Standard Dose
Experimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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