MT10109L in the Treatment of Lateral Canthal Lines
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines (LCL) in participants with moderate to severe LCL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MT10109L MT10109L will be injected into the LCL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. |
Drug: MT10109L
MT10109L will be injected into the LCL.
Other Names:
|
| Placebo Comparator: Placebo Placebo will be injected into the LCL: initial double-blind treatment on Day 1. |
Drug: Placebo
Placebo will be injected into the LCL.
|
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]
- Number of participants with binding and neutralizing antibodies [Day 360]
Eligibility Criteria
Criteria
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 | Moscow scientific-practical centre of dermatovenerology and cosmetology | Moscow | Russian Federation | 127473 | |
| 11 | I.I Mechnikov North-Western State Medical University | Saint-Petersburg | Russian Federation | 194291 | |
| 12 | Expert Aesthetics Ltd | Alderley Edge | Cheshire | United Kingdom | SK9 7ES |
| 13 | Waverley Medical Practice | Coatbridge | North Lanarkshire | United Kingdom | ML5 3AP |
| 14 | Medizen Clinic | Sutton Coldfield | West Midlands | United Kingdom | B74 2UG |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Joan-En Lin, Allergan
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MT10109L-002
- 2014-005279-10