Safety and efficacy of the FTP-002 / FTP-501 combination in the treatment of glabellar lines.
- Conditions
- glabellar lines.Therapeutic area: Not possible to specify
- Registration Number
- CTIS2023-507249-27-00
- Lead Sponsor
- Fastox Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 78
Provision of written informed consent prior to any study related procedures., Female participants naïve for any toxins treatment, between 18 and 55 years of age inclusive., Moderate or severe (Grade 2 or 3) vertical GLs at maximum frown at Baseline (Day 1), as assessed by the Investigator’s Live Assessment (ILA) using a validated 4-point photographic scale (Beer et al., 2019)., Moderate or severe (Grade 2 or 3) vertical GLs at maximum frown at Baseline (Day 1), as assessed by the Subject’s Self-assessment (SSA) using a validated 4-point categorical scale., A negative pregnancy test (for females of childbearing potential only). Nonchildbearing woman is defined as a postmenopausal woman for at least 1 year or a sterile woman (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) for at least 3 months before entering the study., Participant is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visit schedule, concomitant and prohibited therapies, and instruction against sun or UV exposure.
Any prior treatment with permanent fillers in the upper face including the GLs area, Pregnant or lactating women, or childbearing potential women not willing to practice a highly effective form of contraception method at the beginning of the study and for a minimum of 12 weeks following last administration of study treatment; women couple are not concerned by contraception methods and may be enrolled in the study if they fulfil the inclusion/exclusion criteria. Highly effective methods of contraception are defined as methods of birth control which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner (provided that it is the sole male sexual partner of the participant and that the vasectomized partner has received medical assessment of the surgical success), or abstinence(if in line with the preferred and usual lifestyle of the participant)., History of hepatic disease., Participant with a pathology not compatible with the participation of the clinical study in the opinion of the investigator., Positive for hepatitis B antigen, or hepatitis C virus antibody or for human immunodeficiency virus or had received diagnosis for acquired immunodeficiency syndrome., Abnormal ASAT and ALAT liver function values (> 3 ULN)., A history of drug or alcohol abuse., Treatment with an experimental drug or use of any experimental device within 30 days prior to the start of the study and during the conduct of the study., Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant’s participation in the study in the opinion of the investigator., A history of facial nerve palsy., Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin., Any botulinum neurotoxin (BoNT) of any serotype injection in the face, Known allergy or hypersensitivity to BoNT or Dantrolene, or any excipients of FTP-501 or Onabotulinum toxin A (which includes human serum albumin)., The presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgement of the investigator, might increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study., Participant is planning to extensively sun-bath or to overexpose to UV-light (mountains sports, phototherapy, tanning salon use…) during the course of the study, The participant is an adult, protected by the law (adults under guardianship, or hospitalized in a public or private institution for a reason other than the study, or incarcerated), Any prior treatment with long lasting dermal fillers in the face including the GLs area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technique used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the past 12 months or thread lifting if procedure was performed at least 6 months ago; past history of lower face treatments with ultherapy are authorized., Any planned facial cosmetic surgery during the study., A history of eyelid blepharoplasty or brow lift within the past 5 years., An inability to substantially reduce GLs by physically spreading them apart or lac
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method