NCT04715048

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2021

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

4.3 years

First QC Date

January 10, 2021

Last Update Submit

December 7, 2023

Conditions

Glabellar Frown Lines

Keywords

Botox, Jeuveau

Outcome Measures

Primary Outcomes (1)

  • Movement on a 10 point Frown Movement Scale at 3 weeks

    10-point scale created by the investigator assessing movement of glabellar lines. Possible scores range from 0 (no movement) to 10 (movement).

    3 weeks

Secondary Outcomes (6)

  • Days to onset of neurotoxin

    Up to 2-4 days

  • Bruising from the injection on a scale of 1-10

    Up to 2-4 days

  • Pain from the injection on a scale of 1-10

    Up to 2-4 days

  • Headache from the injection on a scale of 1-10

    Up to 2-4 days

  • Movement on a 10 point Frown Movement Scale at 3 weeks

    3 weeks

  • +1 more secondary outcomes

Study Arms (2)

Onabotulinumtoxin A

EXPERIMENTAL

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.

Drug: Onabotulinum toxin A

Prabotulinumtoxin A

EXPERIMENTAL

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.

Drug: PrabotulinumtoxinA

Interventions

PrabotulinumtoxinADRUG

Glabellar line correction

Also known as: Jeuveau
Prabotulinumtoxin A
Onabotulinum toxin ADRUG

Glabellar line correction

Also known as: Botox
Onabotulinumtoxin A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Roski Eye Institute

Los Angeles, California, 90033, United States

Location

Related Publications (1)

  • 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.

    PMID: 30951166BACKGROUND

MeSH Terms

Interventions

prabotulinumtoxin Aonabotulinum toxin ABotulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Ophthalmology; Chief of Oculofacial Plastics Services

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 20, 2021

Study Start

January 1, 2021

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)