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Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

NCT ID: NCT05894109

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2024-10-31

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.

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Detailed Description

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OnabotulinumtoxinA without Zinc Supplementation

Given placebo

Group Type PLACEBO_COMPARATOR

Placebo Microcrystalline Cellulose

Intervention Type OTHER

will take placebo 4 days before and 1 week after botulinum toxin injection

OnabotulinumtoxinA with Zinc Supplementation

Given 50 mg of zinc citrate

Group Type EXPERIMENTAL

zinc citrate 50 mg

Intervention Type DIETARY_SUPPLEMENT

will take zinc citrate 4 days before and 1 week after botulinum toxin injection

Interventions

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zinc citrate 50 mg

will take zinc citrate 4 days before and 1 week after botulinum toxin injection

Intervention Type DIETARY_SUPPLEMENT

Placebo Microcrystalline Cellulose

will take placebo 4 days before and 1 week after botulinum toxin injection

Intervention Type OTHER

Other Intervention Names

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Capsulated Microcrystalline Cellulose

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Wu

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 22453589 (View on PubMed)

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.

Reference Type RESULT
PMID: 33950373 (View on PubMed)

Other Identifiers

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STUDY00006041

Identifier Type: -

Identifier Source: org_study_id

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