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.

Study Overview

• Status: Active, not recruiting
• Conditions: Forehead Rhytid Complex; Glabellar Rhytid Complex
• Intervention / Treatment: Procedure: Botulinum Toxin A

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle contractions; 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.	Procedure: Botulinum Toxin A; Forehead will be injected with Botox.
Active Comparator: No muscle contractions; Patients will be asked to not perform muscle contractions following Botox injections.	Procedure: Botulinum Toxin A; Forehead will be injected with Botox.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale	A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken.	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	Side effects and adverse events will be assessed	13 months
Level of Satisfaction	Patients will be asked to rate their satisfaction	7 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: September 14, 2012
• First Posted (Estimated): September 19, 2012

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: STU56722