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

Glabellar Frown Lines Clinical Trial

Official title:

Split-Face Study Comparing OnabotulinumtoxinA (Botox) and PrabotulinumtoxinA (Jeuveau) in Treating Glabellar Lines

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04715048
• Other study ID #: HS-19-00455
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 1, 2021
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• PrabotulinumtoxinA
Glabellar line correction
• Onabotulinum toxin A
Glabellar line correction

Locations

Country	Name	City	State
United States	USC Roski Eye Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days to onset of neurotoxin	# of days until neurotoxin begins decreasing movement on each side	Up to 2-4 days
Secondary	Bruising from the injection on a scale of 1-10	Post injection bruising measured on a scale from 0 (no bruising) to 10 (most possible bruising) created by the investigator.	Up to 2-4 days
Secondary	Pain from the injection on a scale of 1-10	Post injection pain will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator.	Up to 2-4 days
Secondary	Headache from the injection on a scale of 1-10	Post injection headache will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator.	Up to 2-4 days
Secondary	Movement on a 10 point Frown Movement Scale at 3 weeks	Patients grade their own movement of glabellar lines using a 10-point scale created by the investigator. Possible scores range from 0 (no movement) to 10 (movement).	3 weeks
Secondary	Change in glabellar lines on the Merz Score (0-4)	The Merz Score is a 5 point scale. The Merz Score will be used to grade glabellar lines at rest and frown at both baseline and the 3 week visit. Change will calculated from the 3 week visit compared to baseline.	At baseline and 3 weeks