BridgeMD
Safety and efficacy of the FTP-002 / FTP-501 combination in the treatment of glabellar lines.
EU CTIS ID: 2023-507249-27-00
What this study is testing
Part 1: To evaluate the tolerability/safety of one single intramuscular (IM) injection of FTP-501 in participants with severe GL. Part 2: To evaluate the safety and tolerability of one single IM injection of the combination of FTP-002/FTP-501 versus FTP-002 alone in participants with severe GL.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of written informed consent prior to any study related procedures.
- Female participants naïve for any toxins treatment, between 18 and 65 years of age inclusive.
- Severe (Grade 3) vertical GL at maximum frown at Screening and Baseline (Day 1), as assessed by Investigator’s Live Assessment (ILA) using validated 4-point photographic scale (Beer et al., 2019).
- Severe (Grade 3) vertical GL at maximum frown at Screening and Baseline (Day 1), as assessed by the Subject Self-assessment (SSA) using validated 4-point photographic scale.
- A negative pregnancy test (for females of childbearing potential only). Nonchildbearing female is defined as a premenopausal female with permanent sterility or permanent infertility due to one of the following: • Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy. • Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry for these individuals. Or defined as postmenopausal female; a postmenopausal state is defined as: • Age > 55 years with no menses for 12 or more months without an alternative medical cause. • Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone level > 30 International Unit/L. Females on hormone replacement therapy and whose menopausal status is in doubt, as determined by the investigator, will be required to use one of the non-hormonal (highly) effective contraception methods if they wish to continue their hormone replacement therapy during the study. Otherwise, they must discontinue hormone replacement therapy to allow confirmation of postmenopausal status before study enrolment.
- Participant is willing and able to comply with the requirements of the protocol. In particular, participant must adhere to the visit schedule, concomitant and prohibited therapies, and instruction against sun or ultraviolet (UV) exposure.
You likely can't join if
- Any prior treatment with permanent fillers in the upper face including the GL area.
- 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.
- 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.
See the full eligibility criteria
Who can join
- Provision of written informed consent prior to any study related procedures.
- Female participants naïve for any toxins treatment, between 18 and 65 years of age inclusive.
- Severe (Grade 3) vertical GL at maximum frown at Screening and Baseline (Day 1), as assessed by Investigator’s Live Assessment (ILA) using validated 4-point photographic scale (Beer et al., 2019).
- Severe (Grade 3) vertical GL at maximum frown at Screening and Baseline (Day 1), as assessed by the Subject Self-assessment (SSA) using validated 4-point photographic scale.
- A negative pregnancy test (for females of childbearing potential only). Nonchildbearing female is defined as a premenopausal female with permanent sterility or permanent infertility due to one of the following: • Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy. • Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry for these individuals. Or defined as postmenopausal female; a postmenopausal state is defined as: • Age > 55 years with no menses for 12 or more months without an alternative medical cause. • Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone level > 30 International Unit/L. Females on hormone replacement therapy and whose menopausal status is in doubt, as determined by the investigator, will be required to use one of the non-hormonal (highly) effective contraception methods if they wish to continue their hormone replacement therapy during the study. Otherwise, they must discontinue hormone replacement therapy to allow confirmation of postmenopausal status before study enrolment.
- Participant is willing and able to comply with the requirements of the protocol. In particular, participant must adhere to the visit schedule, concomitant and prohibited therapies, and instruction against sun or ultraviolet (UV) exposure.
What rules you out
- Any prior treatment with permanent fillers in the upper face including the GL area.
- 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.
- 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.
- A history of cardiovascular disease.
- Participant is planning to sun-bath or to overexpose to UV-light (mountain 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 GL 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.
- 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).
- A history of eyelid blepharoplasty or brow lift within the past 5 years.
- An inability to substantially reduce GL by physically spreading them apart or lack of capacity to frown.
- An active infection or other skin problems in the face including the GL area (e.g. acute acne lesions or ulcers).
- Use of concomitant therapy which, in the investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the study treatment, including medications affecting bleeding disorders (antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases including calcium channel blocking agents, such as nifedipine, verapamil, and amlodipine) or potentially hepatotoxic medications/substances.
- Use of medications that affect neuromuscular transmission, such as curare-like nondepolarizing agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days before baseline.
- 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 serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) liver function values (> 3 times upper limit of normal [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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.