Botulinum Toxin A Injection for Forehead Wrinkles and Frown Lines

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Must not be taking: Aminoglycosides, Anticoagulants

Disqualifiers: Pregnancy, Allergies, Bleeding disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking aminoglycosides or anticoagulation therapy.

What data supports the effectiveness of the drug Botulinum Toxin A for forehead wrinkles and frown lines?

Research shows that Botulinum Toxin A is effective in reducing glabellar lines (frown lines between the eyebrows) and forehead wrinkles. In a study, 77% of patients treated with Botulinum Toxin A showed significant improvement in frown lines at 30 days, and the treatment is known for its safety and high patient satisfaction. ^{1 2 3 4 5}

Is Botulinum Toxin A safe for treating forehead wrinkles and frown lines?

Botulinum Toxin A is generally considered safe for cosmetic use, with most side effects being mild and temporary, such as headache, mild pain at the injection site, and rare cases of eyelid drooping. It has an exemplary safety record with no known long-term adverse effects. ^{3 5 6 7 8}

How is the drug Botulinum Toxin A unique for treating forehead wrinkles and frown lines?

Botulinum Toxin A is unique because it works by blocking nerve signals to muscles, causing temporary muscle relaxation and smoothing of dynamic facial lines. Unlike other treatments, it requires repeated injections to maintain its effects, and it is specifically effective for dynamic wrinkles caused by muscle movement. ^{1 2 5 9 10}

What is the purpose of this trial?

This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults aged 18-65 with both static and dynamic forehead/glabellar wrinkles who are in good health and have chosen to receive Botox treatment. Participants must understand the study, consent to it, and commit to follow-up visits. Those with recent cosmetic procedures or botulinum toxin injections, allergies to cow's milk protein or albumin, bleeding disorders, anticoagulant use, active infections in the area (except mild acne), mental illness, pregnancy or lactation are excluded.

Inclusion Criteria

You are in overall good health.

Is willing to return for follow-up visits

I have permanent and movement-related forehead lines.

Exclusion Criteria

Pregnant or lactating

I have had injections to fill in soft tissue areas in the last 2 years.

You have an allergy to albumin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Botox injections with or without muscle contractions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 months

Multiple visits (in-person) at specified intervals

Treatment Details

Interventions

• Botulinum Toxin A

Trial Overview The study tests Botulinum Toxin A (Botox) on forehead/glabellar wrinkles. It examines how quickly it works, its effectiveness, and how long results last when followed by muscle contractions versus no contractions. This cross-over design means participants will experience both scenarios over time.

Participant Groups

Group I: Muscle contractions Experimental Treatment 1 Intervention

Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits.

Group II: No muscle contractions Active Control 1 Intervention

Patients will be asked to not perform muscle contractions following Botox injections.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin A treatment of perioral rhytides. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Botulinum A toxin for glabellar wrinkles. Dose and response. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin injection for facial wrinkles. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Pain associated with injection of botulinum A exotoxin reconstituted using isotonic sodium chloride with and without preservative: a double-blind, randomized controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Botox as Reported in a Food and Drug Administration Database. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with botulinum toxin injection: a multidepartment, retrospective study of 5310 treatments administered to 1819 patients. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Complications with the use of botulinum toxin type A for cosmetic applications and hyperhidrosis. [2010]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Treatment of hyperfunctional facial lines with botulinum toxin]. [2010]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Botulinum toxin A: its expanding role in dermatology and esthetics. [2018]