Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

University of New Mexico (UNM)

Status: Withdrawn

Conditions: 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

Treatments: Dietary Supplement: zinc citrate 50 mg; Other: Placebo Microcrystalline Cellulose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05894109

STUDY00006041

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

OnabotulinumtoxinA without Zinc Supplementation

Placebo Comparator group

Description:

Given placebo

Treatment:

Other: Placebo Microcrystalline Cellulose

OnabotulinumtoxinA with Zinc Supplementation

Experimental group

Description:

Given 50 mg of zinc citrate

Treatment:

Dietary Supplement: zinc citrate 50 mg