Botulinum Toxin Injections for Wrinkles

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Aminoglycosides, Anticoagulants

Disqualifiers: Pregnancy, Allergies, Mental illness, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 visit

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Botox® (Onabotulinum Toxin A) and Xeomin® (Incobotulinum Toxin A) for treating forehead and frown lines. Researchers will compare these treatments by injecting Botox® on one side of the face and Xeomin® on the other. The trial suits individuals aged 20-65 with noticeable forehead and frown lines who have not received similar cosmetic treatments in the past six months. Participants must be in good health and willing to adhere to the study guidelines. As an Early Phase 1 trial, this research seeks to understand how these treatments work in people, allowing participants to contribute to foundational knowledge in cosmetic dermatology.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking aminoglycosides (a type of antibiotic) or are on anticoagulation therapy (blood thinners).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Botox® and Xeomin® are generally safe for treating facial wrinkles.

For Botox®, safety data from over 5,000 participants indicate it is safe and well-tolerated for facial lines, such as those between the eyebrows. At the doses typically used for cosmetic purposes, no serious side effects have been reported.

Studies on Xeomin® also demonstrate it is well-tolerated. Even at higher doses, it remains safe over time, with participants not experiencing major side effects during the studies.

Both treatments are already used to reduce wrinkles and have a good safety record, suggesting they are likely safe options for those considering joining a clinical trial for wrinkle treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Incobotulinum Toxin A and Onabotulinum Toxin A because these treatments offer distinct advantages for reducing facial wrinkles. Both use botulinum toxin, but they differ slightly in formulation and how they might spread in the skin, potentially leading to varied effects on wrinkle smoothing and facial appearance. These treatments could provide alternative options to existing products like Botox, Dysport, or Xeomin, as they might offer unique benefits in terms of effectiveness or side effect profiles. Additionally, exploring these two similar yet distinct toxins helps in understanding which might be more suitable for different patient needs or preferences.

What evidence suggests that this trial's treatments could be effective for wrinkles?

Research has shown that both Onabotulinum Toxin A and Incobotulinum Toxin A effectively reduce forehead and frown lines. In this trial, one side of the face will receive Onabotulinum Toxin A injections, while the other side will receive Incobotulinum Toxin A injections. Studies have found that four weeks after treatment, both options significantly decrease wrinkles compared to a placebo. Onabotulinum Toxin A works especially well for moderate to severe lines, with strong results in clinical reviews. Incobotulinum Toxin A also leads to noticeable improvements, reducing wrinkles by about 40% to 48%. Both treatments have a proven history of making facial lines less visible. ^{3 4 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39475143/

IncobotulinumtoxinA in the Treatment of Upper Facial Lines In both studies, incobotulinumtoxinA treatment was significantly more effective than placebo with respect to the primary endpoints (P < .0001) ...

2. medrxiv.org medrxiv.org/content/10.1101/2025.05.14.25327581v1.full.pdf

Efficacy of Botulinum Toxin Type A in Reducing Facial ... Methods: This review examines clinical outcomes across various facial areas, including glabellar lines, crow's feet, and forehead lines, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8407355/

Botulinum toxin type A for facial wrinkles - PMC At four weeks after injection, all types of botulinum toxin reduced glabellar lines more than a placebo. This effect was seen whether the wrinkles were assessed ...

4. e-aaps.org e-aaps.org/upload/pdf/aaps-2024-01172.pdf

Comparing the efficacy, safety, and satisfaction for ... This study aimed to compare the efficacy and safety of incobotulinum toxin A and abo- botulinum toxin A. Methods This prospective analysis ...

5. healio.com healio.com/news/dermatology/20250610/botulinum-toxin-a-formulations-offer-varying-outcomes-for-frown-lines

Botulinum toxin A formulations offer varying outcomes for ... In contrast, onabotulinum toxin A and incobotulinum toxin A caused reductions ranging from approximately 40% to 48%.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33026771/

IncobotulinumtoxinA Demonstrates Safety and Prolonged ... These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/125360s078lbl.pdf

XEOMIN (incobotulinumtoxinA) - accessdata.fda.gov Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established for lower limb spasticity, sialorrhea, cervical dystonia, ...

8. researchgate.net researchgate.net/publication/345996623_IncobotulinumtoxinA_Demonstrates_Safety_and_Prolonged_Duration_of_Effect_in_a_Dose-Ranging_Study_for_Glabellar_Lines

(PDF) IncobotulinumtoxinA Demonstrates Safety and ... Background: Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy.