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Split-Face Study Comparing Botox and Jeuveau in Treating Glabellar Lines

NCT ID: NCT04715048

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-06-30

Brief Summary

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The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.

Detailed Description

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After being informed about the study and potential risks, all patients given consent will receive Botox on one side of their face and Jueveau on the other. A random number generator will generate a list of 20 combinations of "1,2" or "2,1". "1,2" means the Botox (onabotulinumtoxin A) will be placed on the right side and "2,1" means that the Botox will be placed on the left. The other side will be injected with PrabotulinumtoxinA. 8-10 units will be injected into the designated glabella in 3 sites.

Conditions

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Glabellar Frown Lines

Keywords

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Botox, Jeuveau

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The two different neurotoxins will be drawn into identical appearing syringes by an unblinded investigator. The injector will be a blinded investigator and will not know which syringe has which neurotoxin. There is no difference in appearance of the product when in a standardized syringe. The PI and co-investigator will be graders of these images and will be blinded during the grading process.

Study Groups

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Onabotulinumtoxin A

8-10 units of Botox will be injected in the glabellar lines in one side of the face in 3 different locations. This injection will happen once.

Group Type EXPERIMENTAL

Onabotulinum toxin A

Intervention Type DRUG

Glabellar line correction

Prabotulinumtoxin A

8-10 units of Jeuveau will be injected in the glabellar lines in the other side of the face in 3 different locations. This injection will happen once.

Group Type EXPERIMENTAL

PrabotulinumtoxinA

Intervention Type DRUG

Glabellar line correction

Interventions

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PrabotulinumtoxinA

Glabellar line correction

Intervention Type DRUG

Onabotulinum toxin A

Glabellar line correction

Intervention Type DRUG

Other Intervention Names

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Jeuveau Botox

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Willingness to participate in the study and able to provide informed consent

Exclusion Criteria

* Inability to follow up for study duration
* Prior neurotoxin injection in the last 4 months
* Prior surgery to the glabellar area
* Any planned aesthetic procedure to the glabellar area during the study period
* Cardiac Patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Sandy Zhang-Nunes

Assistant Professor of Clinical Ophthalmology; Chief of Oculofacial Plastics Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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USC Roski Eye Institute

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Rzany BJ, Ascher B, Avelar RL, Bergdahl J, Bertucci V, Bodokh I, Carruthers JA, Cartier H, Delmar H, Denfeld R, Gross JE, Heckmann M, Heden P, Hilton S, Inglefield C, Ogilvie P, Sattler G, Sebastian M, Solish N, Swift A, Trevidic P. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthet Surg J. 2020 Mar 23;40(4):413-429. doi: 10.1093/asj/sjz110.

Reference Type BACKGROUND
PMID: 30951166 (View on PubMed)

Other Identifiers

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HS-19-00455

Identifier Type: -

Identifier Source: org_study_id