Clinical trial NCT04994990: Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles
Official title: Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rhytides
Keywords: Botox
Facial Wrinkles
OnabotulinumtoxinA
Cosmetic
Dosage
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Upper Face Wrinkle Severity 1 Week After Botox Administration
timeFrame: 4 Months
measure: Upper Face Wrinkle Severity 1 Month After Botox Administration
timeFrame: 4 Months
measure: Upper Face Wrinkle Severity 2 Months After Botox Administration
timeFrame: 4 Months
measure: Upper Face Wrinkle Severity 3 Months After Botox Administration
timeFrame: 4 Months
measure: Upper Face Wrinkle Severity 4 Months After Botox Administration
timeFrame: 4 Months
measure: Patient Satisfaction 1 Week After Botox Administration
timeFrame: 4 Months
measure: Patient Satisfaction 1 Month After Botox Administration
timeFrame: 4 Months
measure: Patient Satisfaction 2 Months After Botox Administration
timeFrame: 4 Months
measure: Patient Satisfaction 3 Months After Botox Administration
timeFrame: 4 Months
measure: Patient Satisfaction 4 Months After Botox Administration
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwell Health
name: Nicholas Bastidas, MD
role: PRINCIPAL_INVESTIGATOR
References: