NCT05894109

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

May 30, 2023

Last Update Submit

September 6, 2024

Conditions

Adjuvant Zinc May Increase the Efficacy of Botulinum ToxinZinc Supplementation for Botulinum Toxin Treatment of the ForeheadGlabellar Frown LinesBotulinum Toxin, CosmeticAdjuvant Oral Zinc and Botulinum Toxin

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Side effects of zinc administration

    1 year

Study Arms (2)

OnabotulinumtoxinA without Zinc Supplementation

PLACEBO COMPARATOR

Given placebo

Other: Placebo Microcrystalline Cellulose

OnabotulinumtoxinA with Zinc Supplementation

EXPERIMENTAL

Given 50 mg of zinc citrate

Dietary Supplement: zinc citrate 50 mg

Interventions

zinc citrate 50 mgDIETARY_SUPPLEMENT

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

OnabotulinumtoxinA with Zinc Supplementation
Placebo Microcrystalline CelluloseOTHER

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

Also known as: Capsulated Microcrystalline Cellulose
OnabotulinumtoxinA without Zinc Supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient older than 18 years old who desires botulinum toxin injection to decrease forehead rhytids

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22453589RESULT

  • 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.

    PMID: 33950373RESULT
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 8, 2023

Study Start

August 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share