Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

May 8, 2024 updated by: Jeffrey Wu, University of New Mexico
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00006041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glabellar Frown Lines

Clinical Trials on Placebo Microcrystalline Cellulose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe