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Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

Sponsor
University of New Mexico (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05894109
Collaborator
AbbVie (Industry)
40
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: zinc citrate 50 mg
  • Other: Placebo Microcrystalline Cellulose
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: OnabotulinumtoxinA without Zinc Supplementation

Given placebo

Other: Placebo Microcrystalline Cellulose
will take placebo 4 days before and 1 week after botulinum toxin injection
Other Names:
  • Capsulated Microcrystalline Cellulose

    		•
    Experimental: OnabotulinumtoxinA with Zinc Supplementation

    Given 50 mg of zinc citrate

    Dietary Supplement: zinc citrate 50 mg
    will take zinc citrate 4 days before and 1 week after botulinum toxin injection

    Outcome Measures

    Primary Outcome Measures

    1. Duration of botulinum toxin on eyebrow excursion [1 year]

      Measurement of eyebrow excursion

    2. Duration of botulinum toxin effect on forehead rhytids [1 year]

      Visual assessment of return of forehead rhytids

    Secondary Outcome Measures

    1. Side effects of zinc administration [1 year]

      Monitor for adverse side effects of adjunct oral zinc therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of New Mexico
    • AbbVie

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeffrey Wu, Associate Professor of Surgery, University of New Mexico
    ClinicalTrials.gov Identifier:
    NCT05894109
    Other Study ID Numbers:
    • STUDY00006041
    First Posted:
    Jun 8, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No

    Study Results

    No Results Posted as of Jun 8, 2023