Status:
WITHDRAWN
Botox for Gummy Smile
Lead Sponsor:
Northwestern University
Conditions:
Gingival Exposure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a two part study to measure and observe the efficacy of botulinum toxin A for the treatment of gummy smiles. Part A will randomly compare three different doses of botulinum toxin type A (abob...
Eligibility Criteria
Inclusion
- Written informed consent
- Males or females ≥ 18 years old
- Anterior gingival exposure during smiling larger than 4 mm measured from the central incisor tooth (part A), or 2-4 mm (part B).
- Subjects of childbearing potential who present a negative urine pregnancy test at baseline and use an effective contraceptive method.
- Subjects are in good health as judged by the investigator.
- Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Exclusion
- Pregnant women or women intending to become pregnant in the next 8 months after the screening for eligibility
- Subjects participating in other clinical trials
- Any prior surgery affecting the area of study
- Subjects with neoplastic, muscular or neurological disease
- Subjects who have received botulinum toxin treatment for gummy smile in the previous 12 months before the inclusion date
- Subjects who have received Botulinum toxin treatment for any other cosmetic indication in the previous 6 months before the inclusion date
- Subjects using aminoglycosides and penicillamine antibiotics, quinine or calcium channel blockers
- Subjects with inflammation or active infection in the area to be injected
- Subjects with history of sensitivity to the components of the formulation.
- Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- Subjects who are unable to understand the protocol or give informed consent.
Key Trial Info
Start Date :
April 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03284047
Start Date
April 24 2019
End Date
April 24 2019
Last Update
December 6 2021
Active Locations (1)
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1
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611