Adjuvant Zinc May Increase the Efficacy of Botulinum ToxinNCT05894109
Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids
A study testing zinc citrate 50 mg in people with Adjuvant Zinc May Increase the Efficacy of Botulinum Toxin and Zinc Supplementation for Botulinum Toxin Treatment of the Forehead, run by University of New Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adjuvant Zinc May Increase the Efficacy of Botulinum Toxin, Zinc Supplementation for Botulinum Toxin Treatment of the Forehead, Glabellar Frown Lines
- What is being tested?
- zinc citrate 50 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient older than 18 years old who desires botulinum toxin injection to decrease forehead rhytids
Who cannot join
- 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)
About this study
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
- 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
- Being tested
- zinc citrate 50 mg, Placebo Microcrystalline Cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc citrate 50 mgDietary supplement
will take zinc citrate 4 days before and 1 week after botulinum toxin injection
Placebo Microcrystalline CelluloseOther
Also called Capsulated Microcrystalline Cellulose
will take placebo 4 days before and 1 week after botulinum toxin injection
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA without Zinc Supplementation | Placebo comparator | Given placebo Receives: Other: Placebo Microcrystalline Cellulose |
| OnabotulinumtoxinA with Zinc Supplementation | Experimental | Given 50 mg of zinc citrate Receives: Dietary Supplement: zinc citrate 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of botulinum toxin on eyebrow excursion
Measurement of eyebrow excursion
Measured: 1 year
Duration of botulinum toxin effect on forehead rhytids
Visual assessment of return of forehead rhytids
Measured: 1 year
Secondary outcomes (1)
Side effects of zinc administration
Monitor for adverse side effects of adjunct oral zinc therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study startAug 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: Per the PI, the project is not IRB approved yet and will likely not be completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adjuvant Zinc May Increase the Efficacy of Botulinum ToxinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Jeffrey Wu, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894109
- Sponsor's protocol ID
- STUDY00006041
- Status last verified
- Sep 2024
- First submitted
- 30 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 22453589Shemais 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids
- ClinicalTrials.gov ID
- NCT05894109
- Acronym / sponsor ID
- STUDY00006041
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per the PI, the project is not IRB approved yet and will likely not be completed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- Aug 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Repeated Measures ANOVA (Continuous Data) McNemar Test (Categorical Data)
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA without Zinc Supplementation | Placebo comparator | Other: Placebo Microcrystalline CelluloseGiven placebo |
| OnabotulinumtoxinA with Zinc Supplementation | Experimental | Dietary Supplement: zinc citrate 50 mgGiven 50 mg of zinc citrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient older than 18 years old who desires botulinum toxin injection to decrease forehead rhytids
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc citrate 50 mgwill take zinc citrate 4 days before and 1 week after botulinum toxin injection | Dietary supplement | OnabotulinumtoxinA with Zinc Supplementation |
| Placebo Microcrystalline CelluloseAlso: Capsulated Microcrystalline Cellulosewill take placebo 4 days before and 1 week after botulinum toxin injection | Other | OnabotulinumtoxinA without Zinc Supplementation |
Primary outcome
Duration of botulinum toxin on eyebrow excursion
Time frame: 1 year
Measurement of eyebrow excursion
Duration of botulinum toxin effect on forehead rhytids
Time frame: 1 year
Visual assessment of return of forehead rhytids
1 secondary outcome
Side effects of zinc administration
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 22453589Koshy 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.
- Results publication: PubMed 33950373Shemais 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing zinc citrate 50 mg in people with Adjuvant Zinc May Increase the Efficacy of Botulinum Toxin and Zinc Supplementation for Botulinum Toxin Treatment of the Forehead, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of botulinum toxin on eyebrow excursion (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894109, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.