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A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

Sponsor
Allergan (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05134649
Collaborator
(none)
400
Enrollment
29
Locations
1
Arm
20.8
Anticipated Duration (Months)
13.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 3, open-label study to evaluate the safety of BOTOX Injection in Adult Participants with Platysma Prominence

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 3, Multicenter Open-label Extension Study to Evaluate the Safety of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence
Actual Study Start Date :
Nov 17, 2021
Anticipated Primary Completion Date :
Aug 12, 2023
Anticipated Study Completion Date :
Aug 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BOTOX

BOTOX will be injected into the platysma muscle for up to 3 administrations.

Drug: BOTOX
Intramuscular Injection

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Adverse Events [Day 1 to Day 240]

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period [randomization/treatment with 4-month follow-up visit] and Study Exit visit)
Exclusion Criteria:

  • Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function

  • Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)

  • Anticipated need for surgery or overnight hospitalization during the study

  • Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study

  • Known immunization or hypersensitivity to any botulinum toxin serotype

  • History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months

  • Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable)

  • Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest

Contacts and Locations

Locations

Site City State Country Postal Code
1 Advanced Research Associates - Glendale /ID# 231997 Glendale Arizona United States 85308
2 Clear Dermatology & Aesthetics Center /ID# 231990 Scottsdale Arizona United States 85255-4134
3 Clinical Testing of Beverly Hills /ID# 231986 Encino California United States 91436-2124
4 Steve Yoelin MD Medical Assoc. Inc /ID# 232004 Newport Beach California United States 92663-3311
5 Cosmetic Laser Dermatology /ID# 232414 San Diego California United States 92121-2119
6 Ava T. Shamban MD - Santa Monica. /ID# 232000 Santa Monica California United States 90404-2208
7 Art of Skin MD /ID# 231995 Solana Beach California United States 92075-2228
8 DMR Research PLLC /ID# 231998 Westport Connecticut United States 06880-5369
9 Susan H. Weinkle MD /ID# 232001 Bradenton Florida United States 34209-5642
10 Research Institute of the Southeast, LLC /ID# 231974 West Palm Beach Florida United States 33401-2712
11 Laser and Skin Surgery Center of Indiana /ID# 231983 Indianapolis Indiana United States 46260-2386
12 Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977 Metairie Louisiana United States 70006
13 Delricht Research /ID# 231985 New Orleans Louisiana United States 70115
14 Aesthetic Center at Woodholme /ID# 231996 Baltimore Maryland United States 21208-6391
15 Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002 Hunt Valley Maryland United States 21030-3216
16 Image Dermatology, P.C. /ID# 231980 Montclair New Jersey United States 07042
17 Laser & Skin Surgery Center of New York /ID# 231982 New York New York United States 10016-4974
18 Aesthetic Solutions /ID# 231978 Chapel Hill North Carolina United States 27517-9901
19 Wilmington Dermatology Center /ID# 231981 Wilmington North Carolina United States 28403
20 Aventiv Research Dublin /ID# 231994 Dublin Ohio United States 43016
21 KGL Skin Study Center, LLC /ID# 231993 Newtown Square Pennsylvania United States 19073-2228
22 Nashville Center for Laser and Facial Surgery /ID# 231975 Nashville Tennessee United States 37203-1513
23 Dallas Plastic Surgery Institute /ID# 231999 Dallas Texas United States 75231
24 SkinDC /ID# 231989 Arlington Virginia United States 22209
25 Premier Clinical Research /ID# 232003 Spokane Washington United States 99202
26 Humphrey Cosmetic Dermatology /ID# 239649 Vancouver British Columbia Canada V5Z 4E1
27 Dermetics Cosmetic Dermatology /ID# 239650 Burlington Ontario Canada L7N 3N2
28 Dr Melinda Gooderham Medicine Profession /ID# 239647 Cobourg Ontario Canada K9A 0Z4
29 The Center For Dermatology /ID# 239651 Richmond Hill Ontario Canada L4B 1A5

Sponsors and Collaborators

  • Allergan

Investigators

  • Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT05134649
Other Study ID Numbers:
  • M21-323
First Posted:
Nov 26, 2021
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Allergan
Platysma Prominence
BOTOX
OnabotulinumtoxinA

Study Results

No Results Posted as of Aug 2, 2022