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Per the PI, the project is not IRB approved yet and will likely not be completed.
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA without Zinc Supplementation | Placebo Comparator | Given placebo |
|
| OnabotulinumtoxinA with Zinc Supplementation | Experimental | Given 50 mg of zinc citrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinc citrate 50 mg | Dietary Supplement | will take zinc citrate 4 days before and 1 week after botulinum toxin injection |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects of zinc administration | Monitor for adverse side effects of adjunct oral zinc therapy | 1 year |
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Inclusion Criteria:
Any patient older than 18 years old who desires botulinum toxin injection to decrease forehead rhytids
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22453589 | Result | Koshy JC, Sharabi SE, Feldman EM, Hollier LH Jr, Patrinely JR, Soparkar CN. Effect of dietary zinc and phytase supplementation on botulinum toxin treatments. J Drugs Dermatol. 2012 Apr;11(4):507-12. | |
| 33950373 | Result | Shemais N, Elarab AE, ElNahass H. The effect of botulinum toxin A in patients with excessive gingival display with and without zinc supplementation: randomized clinical trial. Clin Oral Investig. 2021 Nov;25(11):6403-6417. doi: 10.1007/s00784-021-03944-2. Epub 2021 May 5. |
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Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)
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| Placebo Microcrystalline Cellulose | Other | will take placebo 4 days before and 1 week after botulinum toxin injection |
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