Treatment of Forehead/Glabellar Rhytide Complex with Botulinum Toxin a Injection

Northwestern University

Status and phase: Active, not recruiting; Phase 4

Conditions: Glabellar Rhytid Complex; Forehead Rhytid Complex

Treatments: Procedure: Botulinum Toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01688076

STU56722

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Muscle contractions

Experimental group

Description:

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.

Treatment:

Procedure: Botulinum Toxin A

No muscle contractions

Active Comparator group

Description:

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

Treatment:

Procedure: Botulinum Toxin A