Botox for Gummy Smile

NCT03284047 | Withdrawn DMC

• 1 other identifier: STU00205065
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Gingival Exposure

Outcome Measures

Primary Outcomes (1)

• 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]

Study Arms (3)

2.5 U dose

EXPERIMENTAL

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: 1. 2.5 U 2. 5 U 3. 7.5 U

Drug: Botulinum toxin type A

5 U dose

EXPERIMENTAL

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: 1. 2.5 U 2. 5 U 3. 7.5 U

Drug: Botulinum toxin type A

7.5 U dose

EXPERIMENTAL

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: 1. 2.5 U 2. 5 U 3. 7.5 U

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

Participants will be randomized to one of three botulinum toxin type A doses.

2.5 U dose; 5 U dose; 7.5 U dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: April 24, 2019
• Primary Completion: April 24, 2019
• Study Completion: April 24, 2019
• Last Updated: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)