Adjuvant Oral Zinc and Botulinum Toxin, Adjuvant Zinc May Increase the Efficacy of Botulinum Toxin, Botulinum Toxin, Cosmetic, Glabellar Frown Lines, Zinc Supplementation for Botulinum Toxin Treatment of the Forehead
Conditions
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.
Interventions
DIETARY_SUPPLEMENTzinc citrate 50 mg
will take zinc citrate 4 days before and 1 week after botulinum toxin injection
will take placebo 4 days before and 1 week after botulinum toxin injection
Sponsors
AbbVie
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Side effects of zinc administration | 1 year | Monitor for adverse side effects of adjunct oral zinc therapy |
Outcome results
None listed