MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines

Sponsor

Allergan (Industry)

Overall Status

Completed

CT.gov ID

NCT03732833

Collaborator

(none)

424

Enrollment

Locations

Arms

26.7

Actual Duration (Months)

22.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.

Condition or Disease	Intervention/Treatment	Phase
Lateral Canthal Lines, Glabellar Lines	Drug: MT10109L Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

424 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 Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines

Actual Study Start Date :

Nov 5, 2018

Actual Primary Completion Date :

Mar 5, 2020

Actual Study Completion Date :

Jan 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MT10109L Dose 1 + Placebo MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Drug: MT10109L MT10109L will be injected into either the LCL, or both the LCL and GL. Other Names: NivobotulinumtoxinA Drug: Placebo Placebo will be injected into either the GL, or both the LCL and GL.
Experimental: MT10109L Dose 1 + MT10109L Dose 2 MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Drug: MT10109L MT10109L will be injected into either the LCL, or both the LCL and GL. Other Names: NivobotulinumtoxinA
Placebo Comparator: Placebo Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Drug: Placebo Placebo will be injected into either the GL, or both the LCL and GL.

Arm

Intervention/Treatment

Experimental: MT10109L Dose 1 + Placebo

MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Drug: MT10109L

MT10109L will be injected into either the LCL, or both the LCL and GL.

Other Names:

NivobotulinumtoxinA

Drug: Placebo

Placebo will be injected into either the GL, or both the LCL and GL.

Experimental: MT10109L Dose 1 + MT10109L Dose 2

MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Drug: MT10109L

MT10109L will be injected into either the LCL, or both the LCL and GL.

Other Names:

NivobotulinumtoxinA

Placebo Comparator: Placebo

Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Drug: Placebo

Placebo will be injected into either the GL, or both the LCL and GL.

Outcome Measures

Primary Outcome Measures

The proportion of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) according to investigator and participant assessments of LCL severity at maximum smile at Day 30 [Day 30]
The investigator and participant evaluate the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

Secondary Outcome Measures

The duration of LCL treatment in participants who achieved a rating of ≥ 2-grade improvement from baseline in LCL severity at maximum smile at Day 30 according to investigator assessments using the FWS [Day 1 (first treatment) to Day 180]
The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
The proportion of responders for investigator assessments of LCL severity at maximum smile using the FWS [Day 30]
The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
The proportion of participants reporting mostly satisfied/very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 for LCL [Day 60]
The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.
The proportion of responders for investigator assessments of LCL severity at rest using the FWS [Day 30]
The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
Number of patients who experienced an adverse event [From Consent (Screening Visit) up to Day 420]
Mean change from baseline in vital signs [Baseline to Day 360]
Mean change from baseline in Electrocardiogram (ECG) parameters [Baseline to Day 360]
Mean change from baseline in lab parameters [Screening to Day 120]
Number of participants with binding and neutralizing antibodies [Day 360]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

• Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion Criteria

Known immunization or hypersensitivity to any botulinum toxin serotype.
Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
History of facial nerve palsy.
Any uncontrolled systemic disease.
Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
Anticipated need for surgery or overnight hospitalization during the study.
Prior exposure to botulinum toxin of any serotype for any reason.
Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).
Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
Females who are pregnant, nursing, or planning a pregnancy during the study.
Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigate MD	Scottsdale	Arizona	United States	85255
2	Art of Skin MD	Solana Beach	California	United States	92075
3	Susan H. Weinkle, MD	Bradenton	Florida	United States	34209
4	Etre, Cosmetic Dermatology and Laser Center	New Orleans	Louisiana	United States	70130
5	Dermatology and Laser Surgery Center of New York	New York	New York	United States	10028
6	SkinSearch of Rochester, Inc.	Rochester	New York	United States	14623
7	M3 Wake Research, Inc.	Raleigh	North Carolina	United States	27612
8	Wilmington Dermatology Center	Wilmington	North Carolina	United States	28405
9	Aventiv Research, Inc.	Dublin	Ohio	United States	43016
10	Westlake Dermatology & Cosmetic Surgery	Austin	Texas	United States	78746
11	DermResearch, Inc.	Austin	Texas	United States	78759
12	Dr. Jean Carruthers Cosmetic Surgery, Inc.	Vancouver	British Columbia	Canada	V5Z 4E1
13	Pacific Derm	Vancouver	British Columbia	Canada	V6H 4E1
14	Dermetics	Burlington	Ontario	Canada	L7N 3N2
15	Nectar Research Group Inc.	Richmond Hill	Ontario	Canada	L4B 1A5
16	Hautok und Hautok-cosmetics	Munich	Bavaria	Germany	80333
17	Rosenpark-Research	Darmstadt	Hessen	Germany	64283
18	Hautzentrum Köln	Cologne		Germany	50996
19	Medicorum Praxis für Dermatologie und Ästhetik	Oberursel		Germany	61440

Sponsors and Collaborators

Allergan

Investigators

Study Director: Joan-En Lin, Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

Publications

None provided.

Responsible Party:

Allergan

ClinicalTrials.gov Identifier:

NCT03732833

Other Study ID Numbers:

MT10109L-006
2014-005302-38

First Posted:

Nov 7, 2018

Last Update Posted:

Mar 5, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 5, 2021