WithdrawnNCT05894109Updated Sep 19, 2024

Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

An interventional study of zinc citrate 50 mg and Placebo Microcrystalline Cellulose in Adjuvant Zinc May Increase the Efficacy of Botulinum Toxin, Zinc Supplementation for Botulinum Toxin Treatment of the Forehead and Glabellar Frown Lines, sponsored by University of New Mexico. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment

Why this study was withdrawn

Per the PI, the project is not IRB approved yet and will likely not be completed.

Phase: Not applicable
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

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

In context

Lead sponsor

University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 0 participants (actual)

Study arms

Placebo comparator
OnabotulinumtoxinA without Zinc Supplementation
Given placebo
Other: Placebo Microcrystalline Cellulose
Experimental
OnabotulinumtoxinA with Zinc Supplementation
Given 50 mg of zinc citrate
Dietary Supplement: zinc citrate 50 mg

Interventions

Dietary supplementzinc citrate 50 mg
will take zinc citrate 4 days before and 1 week after botulinum toxin injection
OtherPlacebo Microcrystalline Cellulose
will take placebo 4 days before and 1 week after botulinum toxin injection
Also known as: Capsulated Microcrystalline Cellulose

What researchers measure

Primary outcomes

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

Secondary outcomes

Side effects of zinc administration
Monitor for adverse side effects of adjunct oral zinc therapy
Time frame: 1 year

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 22453589 ↗
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. PubMed 33950373 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05894109
Lead sponsor: University of New Mexico
Collaborators: AbbVie
Responsible party: Jeffrey Wu (Associate Professor of Surgery, University of New Mexico) — Principal investigator
First posted: Jun 8, 2023
Start date: Aug 2024 (estimated)
Primary completion: Oct 2024 (estimated)
Completion: Oct 2024 (estimated)
Last update: Sep 19, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of New Mexico

Start the discussion