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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Forehead Rhytid Complex, Glabellar Rhytid Complex

Intervention / Treatment
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* Procedure: Botulinum Toxin A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |