Botox for Gummy Smile

Evaluation of Different Doses of Botulinum Toxin Type A for the Treatment of Gummy Smile

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 (abobotulinumtoxin A) for the treatment of upper anterior gummy smile with larger gingival exposure (> 4 mm).

Part B will assign one of two doses of botulinum toxin type A for participants with smaller gingival exposure (< 4 mm).

Follow-up visits with photography will occur 4 and 12 weeks after their treatment. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

This study is a pilot study designed to determine feasibility of this procedure.

Study Overview

• Status: Withdrawn
• Conditions: Gingival Exposure
• Intervention / Treatment: Drug: Botulinum toxin type A

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent
2. Males or females ≥ 18 years old
3. Anterior gingival exposure during smiling larger than 4 mm measured from the central incisor tooth (part A), or 2-4 mm (part B).
4. Subjects of childbearing potential who present a negative urine pregnancy test at baseline and use an effective contraceptive method.
5. Subjects are in good health as judged by the investigator.
6. 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 Criteria:

1. Pregnant women or women intending to become pregnant in the next 8 months after the screening for eligibility
2. Subjects participating in other clinical trials
3. Any prior surgery affecting the area of study
4. Subjects with neoplastic, muscular or neurological disease
5. Subjects who have received botulinum toxin treatment for gummy smile in the previous 12 months before the inclusion date
6. Subjects who have received Botulinum toxin treatment for any other cosmetic indication in the previous 6 months before the inclusion date
7. Subjects using aminoglycosides and penicillamine antibiotics, quinine or calcium channel blockers
8. Subjects with inflammation or active infection in the area to be injected
9. Subjects with history of sensitivity to the components of the formulation.
10. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
11. Subjects who are unable to understand the protocol or give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2.5 U dose; Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows: 2.5 U; 5 U; 7.5 U	Drug: Botulinum toxin type A; Participants will be randomized to one of three botulinum toxin type A doses.
EXPERIMENTAL: 5 U dose; Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows: 2.5 U; 5 U; 7.5 U	Drug: Botulinum toxin type A; Participants will be randomized to one of three botulinum toxin type A doses.
EXPERIMENTAL: 7.5 U dose; Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows: 2.5 U; 5 U; 7.5 U	Drug: Botulinum toxin type A; Participants will be randomized to one of three botulinum toxin type A doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the upper gum exposure at 4 weeks and 12 weeks.	Reduction in millimeters in the upper gum exposure of subjects after botulinum toxin type A (abobotulinumtoxin A) treatment.	[Baseline, 4 weeks,12 weeks]

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 24, 2019
• Primary Completion (ANTICIPATED): April 24, 2019
• Study Completion (ANTICIPATED): April 24, 2019

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (ACTUAL): September 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: STU00205065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No