Botox for Gummy Smile

• Sponsor: Northwestern University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03284047
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Exposure	Drug: Botulinum toxin type A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Different Doses of Botulinum Toxin Type A for the Treatment of Gummy Smile
• Anticipated Study Start Date: Apr 24, 2019
• Anticipated Primary Completion Date: Apr 24, 2019
• Anticipated Study Completion Date: Apr 24, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Reduction of the upper gum exposure at 4 weeks and 12 weeks. [[Baseline, 4 weeks,12 weeks]]

   Reduction in millimeters in the upper gum exposure of subjects after botulinum toxin type A (abobotulinumtoxin A) treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
• ClinicalTrials.gov Identifier: NCT03284047
• Other Study ID Numbers: STU00205065
• First Posted: Sep 15, 2017
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of Dec 6, 2021