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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05894109
Other study ID # STUDY00006041
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date October 2024

Study information

Verified date May 2024
Source University of New Mexico
Contact Addi Moya, BS
Phone 505-272-2336
Email adnmoya@salud.unm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
zinc citrate 50 mg
will take zinc citrate 4 days before and 1 week after botulinum toxin injection
Other:
Placebo Microcrystalline Cellulose
will take placebo 4 days before and 1 week after botulinum toxin injection

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of New Mexico AbbVie

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of botulinum toxin on eyebrow excursion Measurement of eyebrow excursion 1 year
Primary Duration of botulinum toxin effect on forehead rhytids Visual assessment of return of forehead rhytids 1 year
Secondary Side effects of zinc administration Monitor for adverse side effects of adjunct oral zinc therapy 1 year
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