ClinicalTrials.gov
ClinicalTrials.gov Menu

MT10109L in the Treatment of Glabellar Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03795922
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.

Condition or disease Intervention/treatment Phase
Glabellar Lines Drug: MT10109L Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 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
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Experimental: MT10109L
MT10109L will be injected into the GL: 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 GL.
Other Name: NivobotulinumtoxinA

Placebo Comparator: Placebo
Placebo will be injected into the GL: initial double-blind treatment on Day 1.
Drug: Placebo
Placebo will be injected into the GL.




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 [ Time Frame: 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 effect 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 60 ]
    The Satisfaction Question 5 grades frown 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 [ Time Frame: Day 30 ]
    The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795922


Contacts
Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com

Locations
United States, Arizona
Investigate MD Not yet recruiting
Scottsdale, Arizona, United States, 85255
United States, California
Art of Skin MD Not yet recruiting
Solana Beach, California, United States, 92075
United States, Louisiana
Etre, Cosmetic Dermatology and Laser Center Not yet recruiting
New Orleans, Louisiana, United States, 70130
United States, New York
Dermatology and Laser Surgery Center of New York Not yet recruiting
New York, New York, United States, 10028
SkinSearch of Rochester, Inc. Not yet recruiting
Rochester, New York, United States, 14623
United States, North Carolina
M3 Wake Research, Inc. Not yet recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Aventiv Research, Inc. Not yet recruiting
Dublin, Ohio, United States, 43016
United States, Texas
Westlake Dermatology & Cosmetic Surgery Not yet recruiting
Austin, Texas, United States, 78746
Sponsors and Collaborators
Allergan
Investigators
Study Director: Cheri Mao Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03795922     History of Changes
Other Study ID Numbers: MT10109L-001
2014-005300-16 ( EudraCT Number )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No