Clinical trial NCT01688076: Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection
Official title: Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Forehead Rhytid Complex
Glabellar Rhytid Complex
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
timeFrame: 13 months
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 13 months
measure: Level of Satisfaction
timeFrame: 7 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: