Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection

Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment

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.

In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.

Inclusion Criteria:

• In good health
• Is 18-65 years of age
• Has static and dynamic forehead/glabellar wrinkles
• Has decided to receive Botox® treatment for their forehead/glabellar wrinkles
• Has the willingness and ability to understand and provide informed consent and communicate with the investigator
• Is willing to return for follow-up visits

Exclusion Criteria:

• Pregnant or lactating

• Has received the following treatments in the forehead or glabellar region:

  • botulinum toxin injections in the past 6 months
  • ablative laser procedure in the past 6 months
  • radiofrequency device treatment in the past 6 months
  • ultrasound device treatment in the past 6 months
  • medium to deep chemical peel in the past 6 months
  • temporary soft tissue augmentation material in the past year
  • semi-permanent soft tissue augmentation material in the past 2 years
  • permanent soft tissue augmentation material

• Is planning to receive within the next year, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.

• Is planning to use tretinoin or retinoic acid in the next year

• Has an active infection in the forehead or glabellar region (excluding mild acne)

• Is allergic to cow's-milk protein

• Is allergic to albumin

• Taking aminoglycoside

• Is currently using anticoagulation therapy

• Has a history of bleeding disorders

• Is unable to understand the protocol or to give informed consent

• Is unable to return for follow-up visits

• Has a mental illness