Glabellar Frown Lines Clinical Trial
Official title:
Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids
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.
| 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) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of New Mexico | AbbVie |
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
| 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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