Effective AbobotulinumtoxinA Split Face Dose Response Study for Upper Facial Wrinkles

Sponsor

Nicholas Bastidas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04994990

Collaborator

(none)

Enrollment

Arms

7.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhytides	Drug: AbobotulinumtoxinA Drug: AbobotulinumtoxinA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Effective AbobotulinumtoxinA Split Face Dose Response Study for Upper Facial Wrinkles

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Left Side of Face Receiving Double Dose	Drug: AbobotulinumtoxinA Half of face will receive standard dose of Botox Drug: AbobotulinumtoxinA Half of face will receive double the standard dose of Botox
Experimental: Right Side of Face Receiving Double Dose	Drug: AbobotulinumtoxinA Half of face will receive standard dose of Botox Drug: AbobotulinumtoxinA Half of face will receive double the standard dose of Botox

Arm

Intervention/Treatment

Experimental: Left Side of Face Receiving Double Dose

Drug: AbobotulinumtoxinA

Half of face will receive standard dose of Botox

Drug: AbobotulinumtoxinA

Half of face will receive double the standard dose of Botox

Experimental: Right Side of Face Receiving Double Dose

Drug: AbobotulinumtoxinA

Half of face will receive standard dose of Botox

Drug: AbobotulinumtoxinA

Half of face will receive double the standard dose of Botox

Outcome Measures

Primary Outcome Measures

Upper Face Wrinkle Severity 1 Week After Botox Administration [4 Months]
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.
Upper Face Wrinkle Severity 1 Month After Botox Administration [4 Months]
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.
Upper Face Wrinkle Severity 2 Months After Botox Administration [4 Months]
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.
Upper Face Wrinkle Severity 3 Months After Botox Administration [4 Months]
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.
Upper Face Wrinkle Severity 4 Months After Botox Administration [4 Months]
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.
Patient Satisfaction 1 Week After Botox Administration [4 Months]
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
Patient Satisfaction 1 Month After Botox Administration [4 Months]
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
Patient Satisfaction 2 Months After Botox Administration [4 Months]
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
Patient Satisfaction 3 Months After Botox Administration [4 Months]
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
Patient Satisfaction 4 Months After Botox Administration [4 Months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.