Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

Not Applicable

Not yet recruiting

• Conditions: Botulinum Toxin, Cosmetic; Zinc Supplementation for Botulinum Toxin Treatment of the Forehead; Adjuvant Zinc May Increase the Efficacy of Botulinum Toxin; Adjuvant Oral Zinc and Botulinum Toxin; Glabellar Frown Lines
• Interventions: Other: Placebo Microcrystalline Cellulose; Dietary Supplement: zinc citrate 50 mg

• Registration Number: NCT05894109
• Lead Sponsor: University of New Mexico

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Study Start: 2024-08
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OnabotulinumtoxinA without Zinc Supplementation	Placebo Microcrystalline Cellulose	Given placebo
OnabotulinumtoxinA with Zinc Supplementation	zinc citrate 50 mg	Given 50 mg of zinc citrate

Primary Outcome Measures

Name	Time	Method
Duration of botulinum toxin on eyebrow excursion	1 year	Measurement of eyebrow excursion
Duration of botulinum toxin effect on forehead rhytids	1 year	Visual assessment of return of forehead rhytids

Secondary Outcome Measures

Name	Time	Method
Side effects of zinc administration	1 year	Monitor for adverse side effects of adjunct oral zinc therapy