Botulinum Toxin Injections for Wrinkles

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 visit

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for healthy adults aged 20-65 with moderate forehead and glabellar wrinkles who can give informed consent. It's not for those under 20 or over 65, pregnant/lactating women, people with bleeding disorders, mental illness, recent cosmetic procedures in the treatment area, or allergies to cow's milk protein or albumin.

Inclusion Criteria

You are between 20 and 65 years old.

Both females and males

You are in generally good physical condition.

Exclusion Criteria

Unable to understand the protocol or to give informed consent

Taking aminoglycoside

You have a history of problems with bleeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants are injected with onabotulinum toxin A on one side and incobotulinum toxin A on the other side during their first clinic visit

1 visit

1 visit (in-person)

Follow-up

Participants return for follow-up visits to have photographs taken at relaxed and full contraction

6 months

6 visits (in-person)

Treatment Details

Interventions

• Incobotulinum Toxin A
• Onabotulinum Toxin A

Trial Overview The study compares Botox® (Onabotulinum Toxin A) and Xeomin® (Incobotulinum Toxin A) to see which is more effective at treating forehead and glabellar wrinkles. Participants will receive injections of either product.

Participant Groups

Group I: Onabotulinum Toxin A Active Control 1 Intervention

One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face.

Group II: Incobotulinum Toxin A Active Control 1 Intervention

The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+