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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03721016
• Collaborator: (none)
• Enrollment: 415
• Locations: 18
• Arms: 3
• Actual Duration (Months): 26.9
• Patients Per Site: 23.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 415 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 Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines
• Actual Study Start Date: Oct 26, 2018
• Actual Primary Completion Date: Mar 5, 2020
• Actual Study Completion Date: Jan 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MT10109L Dose 1 + Placebo MT10109L Dose 1 will be injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Drug: MT10109L; MT10109Lwill be injected into either the GL, LCL, or both.; Other Names: NivobotulinumtoxinA ; Drug: Placebo; Placebo will be injected into either the GL, LCL, or both.
Experimental: MT10109L Dose 1 + MT10109L Dose 2 MT10109L Dose 1 will be injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.	Drug: MT10109L; MT10109Lwill be injected into either the GL, LCL, or both.; Other Names: NivobotulinumtoxinA
Placebo Comparator: Placebo Placebo will be injected into the GL and into the LCL: 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, LCL, or both.

Outcome Measures

Primary Outcome Measures

1. 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 GL severity at maximum frown at Day 30 [Day 30]

   The investigator and participant evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

Secondary Outcome Measures

1. The duration of GL treatment in participants who achieved a rating of ≥ 2-grade improvement from baseline in GL severity at maximum frown at Day 30 according to investigator assessments using the FWS [Day 1 (first treatment) to Day 180]

   The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

2. The proportion of responders for investigator assessments of GL severity at maximum frown using the FWS [Day 30]

   The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.

3. The proportion of participants reporting mostly satisfied/very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 for GL [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.

4. The proportion of responders for investigator assessments of GL severity at rest using the FWS [Day 30]

   The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.

5. Number of patients who experienced an adverse event [From Consent (Screening Visit) up to Day 420]

6. Mean change from baseline in vital signs [Baseline to Day 360]

7. Mean change from baseline in Electrocardiogram (ECG) parameters [Baseline to Day 360]

8. Mean change from baseline in lab parameters [Screening to Day 120]

9. 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: No

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	Advanced Research Associates	Glendale	Arizona	United States	85308
2	Eye Research Foundation	Newport Beach	California	United States	92663
3	Skin Research Institute LLC	Coral Gables	Florida	United States	33146
4	Coleman Dermatologic Surgery Center	Metairie	Louisiana	United States	70006
5	Maryland Laser, Skin, & Vein Institute	Hunt Valley	Maryland	United States	21030
6	Laser Skin Surgery Center of New York	New York	New York	United States	10016
7	Bellaire Dermatology Associates	Bellaire	Texas	United States	77401
8	SkinDC	Arlington	Virginia	United States	22209
9	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502
10	Carruthers & Humphrey Clinical Research	Vancouver	British Columbia	Canada	V5Z 4E1
11	Project Skin MD	Vancouver	British Columbia	Canada	V6H 1K9
12	Sweat Clinics of Canada	Toronto	Ontario	Canada	M5R 3N8
13	Bertucci MedSpa Inc.	Woodbridge	Ontario	Canada	L4L 8E2
14	Studienzentrum Theatiner46	Munich	Bavaria	Germany	80333
15	DRK-Kliniken Nordhessen	Kassel	Hessen	Germany	34121
16	Privatpraxis Dr. Hilton & Partner	Düsseldorf	NRW	Germany	40212
17	Bermuda Practice	Basingstoke	Hampshire	United Kingdom	RG24 9DT
18	The Bosham Clinic	Chichester	West Sussex	United Kingdom	PO18 8AN

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 [e-mail] for assistance.

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03721016
• Other Study ID Numbers: MT10109L-005; 2014-005301-21
• First Posted: Oct 26, 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: No

Study Results

No Results Posted as of Mar 5, 2021