A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Sponsor

Allergan (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05100199

Collaborator

(none)

328

Enrollment

Locations

Arms

13.7

Anticipated Duration (Months)

18.2

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.

Condition or Disease	Intervention/Treatment	Phase
Glabellar Lines	Drug: OnabotulinumtoxinA X Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

328 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of OnabotulinumtoxinA X for the Treatment of Moderate to Severe Glabellar Lines

Actual Study Start Date :

Oct 6, 2021

Anticipated Primary Completion Date :

Nov 26, 2022

Anticipated Study Completion Date :

Nov 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo will be injected into the Glabellar Complex on Day 1.	Drug: Placebo Injection
Experimental: OnabotulinumtoxinA X Dose A OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.	Drug: OnabotulinumtoxinA X Injection
Experimental: OnabotulinumtoxinA X Dose B OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.	Drug: OnabotulinumtoxinA X Injection
Experimental: OnabotulinumtoxinA X Dose C OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.	Drug: OnabotulinumtoxinA X Injection

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline as rated by investigator using the Clinician Glabellar Lines Scale. [Day 1 to Day 30]
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Percentage of Participants With Adverse Events (AEs) [Day 1 to Day 270]
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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of 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 study drug.

Secondary Outcome Measures

Percentage of Participants with Achievement of None or Mild as rated by investigator using the Clinician Glabellar Lines Scale. [Day 1 to Day 30]
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Percentage of Participants with Achievement of improvement per the Facial Lines Satisfaction Questionnaire Impact domain, among subjects with baseline scores of 14 points or greater. [Day 1 to Day 30]
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
Percentage of Participants with Achievement of satisfaction with treatment per the Facial Line Satisfaction Questionnaire Item 5. [Day 1 to Day 60]
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator.
Participant has moderate or severe GL at maximum frown.

Exclusion Criteria:

History of known immunization to any botulinum toxin serotype.
History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including:
Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
Facial nerve palsy.
Infection or dermatological condition at the site of study drug injection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Research Associates - Glendale /ID# 230418	Glendale	Arizona	United States	85308
2	Westside Aesthetics /ID# 230305	Los Angeles	California	United States	90025-1708
3	The Eye Research Foundation /ID# 232544	Newport Beach	California	United States	92663-3637
4	The Research Center at The Maas Clinic /ID# 230685	San Francisco	California	United States	94115-1809
5	Center for Dermatology and Dermatologic Surgery /ID# 230684	Washington	District of Columbia	United States	20037-1445
6	Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542	Boca Raton	Florida	United States	33431-6465
7	Baumann Cosmetic and Research Institute /ID# 232545	Miami	Florida	United States	33137-3254
8	Research Institute of the Southeast, LLC /ID# 230436	West Palm Beach	Florida	United States	33401-2712
9	Coleman Center For Cosmetic Dermatologic Surgery /ID# 230693	Metairie	Louisiana	United States	70006
10	Etre Cosmetic Dermatology and Laser Center /ID# 230437	New Orleans	Louisiana	United States	70130-4353
11	SLUCare Cosmetic Dermatology /ID# 230333	Saint Louis	Missouri	United States	63122-3379
12	Laser & Skin Surgery Center of New York /ID# 230683	New York	New York	United States	10016-4974
13	Skin Search of Rochester Inc. /ID# 242540	Rochester	New York	United States	14623
14	Aesthetic Solutions /ID# 230716	Chapel Hill	North Carolina	United States	27517-9901
15	Wilmington Dermatology Center /ID# 242544	Wilmington	North Carolina	United States	28403
16	Aventiv Research Dublin /ID# 232546	Dublin	Ohio	United States	43016
17	Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232543	Austin	Texas	United States	78746-4720
18	Premier Clinical Research /ID# 230682	Spokane	Washington	United States	99202

Sponsors and Collaborators

Allergan

Investigators

Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allergan

ClinicalTrials.gov Identifier:

NCT05100199

Other Study ID Numbers:

2042-201-008

First Posted:

Oct 29, 2021

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 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:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Allergan

OnabotulinumtoxinA X

BOTOX

Glabellar Lines

Additional relevant MeSH terms:

Botulinum Toxins, Type A

abobotulinumtoxinA

Study Results

No Results Posted as of Apr 20, 2022