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Tests treatment safety and results for Moderate to Severe Glabellar Lines
Official title A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
ClinicalTrials.gov ID: NCT07435428
What this study is testing
What is IPN10200?
IPN10200 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for moderate to severe glabellar lines.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the effectiveness and safety of a single dose of IPN10200 compared to placebo (double-blind phase) and how well and safely repeat doses of IPN10200 work over time (open-label phase) in adult participants with moderate to severe glabellar lines. Glabellar lines are wrinkle-like lines that appear between the eyebrows and can become more noticeable with age or repeated facial expressions.
- Phase 3: a large, late-stage study
- Time commitment: about 107 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Participant should be male or female, ≥18 years of age at the time of signing the informed consent.
- Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.
- Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.
- Are 'dissatisfied' or 'very dissatisfied' with their GLs at baseline, as assessed by the SLS score.
- For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those...
You likely can't join if
- An active infection or other skin problems in the upper face including the GL area (e.g. acute acne lesions or ulcers).
- A history of eyelid blepharoplasty or brow lift or any other upper facial surgery within the past 5 years.
- A history of facial nerve palsy.
- Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
- Closed-angle glaucoma or a predisposition to it (for Japan only).
- Any known medical condition that may put the participant at increased risk with regard to exposure to BoNT of any serotype (i.e. myasthenia gravis...
See the full eligibility criteria
Who can join
- Participant should be male or female, ≥18 years of age at the time of signing the informed consent.
- Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.
- Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.
- Are 'dissatisfied' or 'very dissatisfied' with their GLs at baseline, as assessed by the SLS score.
- For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Participant has both the time and ability to complete the study and comply with study instructions.
- Does not reside in an institution by administrative or court order.
- Is not a sponsor employee or clinical research unit personnel directly affiliated with the study or is not an immediate family member. Immediate family is defined as a spouse, parent, child or sibling whether biological...
What rules you out
- An active infection or other skin problems in the upper face including the GL area (e.g. acute acne lesions or ulcers).
- A history of eyelid blepharoplasty or brow lift or any other upper facial surgery within the past 5 years.
- A history of facial nerve palsy.
- Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
- Closed-angle glaucoma or a predisposition to it (for Japan only).
- Any known medical condition that may put the participant at increased risk with regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.).
- Presence of any scars, piercings, or tattoos (including microblading of the eyebrows) in or around the treatment area that have occurred within 6 months prior to baseline, or which in the investigator's opinion, could...
- Administration of any BoNT (other than the study intervention) into any site of the body and for any indication from 9 months prior to the first study visit until the end of the study.
- Treatment with IPN10200 in any prior study.
- Use of medications that affect neuromuscular transmission (such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases) within the past 30 days prior to baseline is prohibited or a longer...
- Use of aminoglycoside antibiotics within the past 30 days prior to baseline are prohibited. Note: Topical use apart from the area of injection would be acceptable.
- Use of systemic retinoids within the past 30 days prior to baseline and planned use during the study. Note: Topical retinoids are allowed other than in the areas that will be injected (upper facial area) at the...
- Any prior treatment with permanent fillers, lifting threads, autologous fat or permanent procedures in the upper face including the GL area.
- Administration of any nonpermanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid or polymethyl-methacrylate) for soft tissue augmentation therapy in the GL region within 12 months...
- Any prior facial treatment or aesthetic procedures to the upper face including photorejuvenation, vascular or pigment laser or microneedling within the 3 months prior to baseline.
- Any prior facial treatment or aesthetic procedures to the upper face involving skin resurfacing (including dermabrasion, laser, or whatever the treatment technique used) or chemical peel within the past 12 months prior...
- Any planned cosmetic surgery or aesthetic procedures to the upper face during the study and/or any procedures to other parts of the face which in the investigator's opinion, could interfere with evaluations during the...
- Any past surgery in the upper facial line area including GL.
- Planned use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or how well it works of the study intervention. Therapy considered necessary for the...
- Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half-life is...
- Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus or a diagnosis of acquired immunodeficiency syndrome.
- 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.
- An inability to substantially lessen GL as determined by the investigator.
- Known allergy or hypersensitivity to BoNT or any excipients of IPN10200.
- A history of chronic or recreational drug abuse as assessed by the investigator.
- Any uncontrolled systemic disease or other significant medical condition which would be harmful for the participant to be entered into the study or continue participation.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Newport Beach, California, United States
- Pasadena, California, United States
- San Diego, California, United States
- Santa Ana, California, United States
- Westport, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Aventura, Florida, United States
- Bradenton, Florida, United States
- Coral Gables, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lincolnshire, Illinois, United States
- Indianapolis, Indiana, United States
- Metairie, Louisiana, United States
- New Orleans, Louisiana, United States
- Hunt Valley, Maryland, United States
- Rockville, Maryland, United States
- Chestnut Hill, Massachusetts, United States
+ 33 more site(s).
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 study runs about 107 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Newport Beach, California, United States; Pasadena, California, United States; San Diego, California, United States; Santa Ana, California, United States; Westport, Connecticut, United States and 47 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.