MT10109L in the Long-term, Open-label Treatment of Glabellar Lines and Lateral Canthal Lines
- Conditions
- Glabellar Lines & Lateral Canthal LinesMedDRA version: 21.1Level: LLTClassification code 10052609Term: Glabellar frown linesSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-005303-24-BE
- Lead Sponsor
- Medytox Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
- Completion of lead-in Phase 3 study: Study MT10109L-001 for GL participants, Study MT10109L-002 for LCL participants, Studies MT10109L-005 or-006 for GL and LCL participants.
- Stable medical condition, in the opinion of the investigator
- 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 as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the 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 760
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
- 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 brow or eyelid ptosis, as determined by the investigator
- Infection or skin disorder at the injection sites
- Any uncontrolled systemic disease
- Recent history of alcohol or drug abuse based on the investigator’s judgement
- 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
- Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study, except the prior qualifying lead-in Phase 3 study
- Females who are pregnant, nursing, or planning a pregnancy during the study. Females of childbearing potential, not using a reliable means of contraception.
- 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 opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Blood samples for immunogenicity testing will be collected on during the retreatment visit and the at the visit 30 days later. This will allow us to detect presence of binding and neutralizing antibodies. <br><br>Vital signs will be performed during the retreatment visit and the at the visit 30 days later. This will allow us to detect changes from baseline. <br><br>;Main Objective: To evaluate the long-term safety of repeat treatments of MT10109L in participants with moderate to severe GL, LCL, or both (GL and LCL);Secondary Objective: The proportion of participants with none of mild adverse events, a high<br>satisfaction rate, and improvement rate from baseline;;Primary end point(s): Incidence of adverse events, change from baseline in vital signs, and presence of binding and neutralizing antibodies
- Secondary Outcome Measures
Name Time Method