EUCTR2018-004384-31-BEActive, not recruitingPhase 1
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. - MT10109L in the Treatment of Glabellar Lines
Allergan Ltd.0 sites225 target enrollmentStarted: June 3, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 225
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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.
- •- Moderate to severe GL at maximum frown (as assessed by both the investigator and participant; investigator and participant ratings must be the same) using the FWS.
- •- Participants must have sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their GL lines, 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
Exclusion Criteria
- •- 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 GL severity using FWS.
- •- 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 brow 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.
- •- Prior exposure to botulinum toxin of any serotype for any reason
- •- 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, mid-facial, 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 immediate area of the study site that would preclude them from returning for all protocol specified study visits.
- •- Participants who, in the investigator’s opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period.
- •- The participant has a condition or is in a situation which, in the investigator’s opini
Investigators
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