MT10109L in the Treatment of Lateral Canthal Lines
- Conditions
- ateral Canthal LinesMedDRA version: 21.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-005279-10-GB
- Lead Sponsor
- Allergan Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 225
- Participant must be = 18 years of age and considered to be an adult in her/his local jurisdiction at the time of signing the informed consent.
- Bilaterally symmetrical moderate to severe lateral canthal lines (LCL) at maximum smile (same grade on both sides of the face as assessed by both the investigator and participant; investigator and participant ratings must be the same) using the Facial Wrinkle Scale with Photonumeric Guide (FWS).
- Participants must have sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their LCL, in the opinion of the investigator.
- Male and female
- Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
- Female participants of childbearing potential must have a negative urine pregnancy test before each study intervention. A female is considered NOT to be of childbearing potential if she is premenarchal, postmenopausal (at least 12 consecutive months without menstruation), or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral oophorectomy).
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Written informed consent from the participant has been obtained prior to any study-related procedures.
- Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable. (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
- Ability to follow study instructions, including completing study assessment tools without any assistance or alteration to the assessment tools and likely to complete all required visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9
- Any condition which precludes a participant’s ability to comply with study requirements, including completion of the study visits or inability to read, understand, and/or self-assess lateral canthal lines (LCL) severity using the Facial Wrinkle Scale with Photonumeric Guide (FWS) with Photonumeric Guide.
- 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.
- Any history of significant cardiovascular disease, family history of long QT syndrome, or a clinically significant electrocardiogram (ECG) abnormality at the Screening Visit.
- Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial lines even by physically spreading them apart, as determined by the investigator.
- Any eyebrow or eyelid ptosis, as determined by the investigator.
- Infection or skin disorder at the injection sites.
- History of facial nerve palsy.
- Any uncontrolled systemic disease.
- Recent history of alcohol or drug abuse based on the investigator’s judgment
- 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.
- Any of the following procedures or treatments occurring in the specified period before enrollment (Day 1):
- 3 months: any facial nonablative resurfacing laser, light or ultrasound treatment, microdermabrasion, or superficial peels
- 6 months: any facial cosmetic procedure with medium depth or deep depth chemical peels (eg, trichloroacetic acid [TCA] and phenol); periorbital, midfacial, or upper-facial skin resurfacing; or permanent make-up in the mid-facial (extending from inferior orbital margin to level of the nasal base) or upper facial areas
- 12 months: any periorbital, mid-facial, or upper-facial treatment with nonpermanent soft tissue fillers
- Participants on topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 6 months before enrollment and who are unable to maintain the same regimen for the study.
- Participants on oral retinoid therapy within 1 year before study enrollment.
- 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 immedi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy between 24 U MT10109L and placebo for the treatment of lateral canthal Lines (LCL);Secondary Objective: Not Applicable;Primary end point(s): The proportion of participants achieving a rating of none or mild on the FWS according to investigator and participant assessments of LCL severity at maximum smile at Day 30;Timepoint(s) of evaluation of this end point: Day 30
- Secondary Outcome Measures
Name Time Method