Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

Study Overview
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Brief Summary
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The current literature suggests that zinc supplementation may increase the duration of botulinum toxin; however, each study had their limitations. Further, no one has studied the effect of zinc supplementation for botulinum toxin treatment of the forehead. The purpose of this study is to evaluate the effect of zinc supplementation on frontalis muscle denervation by objectively assessing the degree of forehead rhytids and movement of the eyebrows.

Official Title
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Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

Conditions
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Adjuvant Zinc May Increase the Efficacy of Botulinum Toxin, Zinc Supplementation for Botulinum Toxin Treatment of the Forehead, Glabellar Frown Lines, Botulinum Toxin, Cosmetic, Adjuvant Oral Zinc and Botulinum Toxin

Intervention / Treatment
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* Dietary Supplement: zinc citrate 50 mg
* Other: Placebo Microcrystalline Cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient older than 18 years old who desires botulinum toxin injection to decrease forehead rhytids Exclusion Criteria: Allergy to any components of zinc citrate or botulinum toxin inflammation or infection at site of injection patients using anticholineresterase or other agents interfering with neuromuscular transmission patients with any medical condition that can affect frontalis function (Bell's palsy, Möbius syndrome, Hemifacial microsomia, CHARGE syndrome, stroke, etc) patients with any prior trauma that could have potentially injured the frontalis muscle patients dependent on intact facial movements and expressions for their livelihood (actors, singers, musicians, etc)

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: OnabotulinumtoxinA without Zinc Supplementation<br>Given placebo | Other: Placebo Microcrystalline Cellulose<br>* will take placebo 4 days before and 1 week after botulinum toxin injection<br>* Other names: Capsulated Microcrystalline Cellulose;|
| Experimental: OnabotulinumtoxinA with Zinc Supplementation<br>Given 50 mg of zinc citrate | Dietary Supplement: zinc citrate 50 mg<br>* will take zinc citrate 4 days before and 1 week after botulinum toxin injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of botulinum toxin on eyebrow excursion | Measurement of eyebrow excursion | 1 year | 
| Duration of botulinum toxin effect on forehead rhytids | Visual assessment of return of forehead rhytids | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of zinc administration | Monitor for adverse side effects of adjunct oral zinc therapy | 1 year |