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IPN10200 for moderate to severe frown (glabellar) lines

A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled and Open-label Study to Evaluate the Efficacy and Safety of a Single Dose of IPN10200 in the Improvement of Moderate to Severe Glabellar Lines in Adult Participants, and to Evaluate the Long-term Efficacy and Safety of Repeat Doses of IPN10200 in the Same Indication

Phase 3 Interventional Ipsen · NCT07435428

This trial will test whether a single dose and repeat doses of IPN10200 can safely reduce moderate to severe glabellar (frown) lines in adults.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1300 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorIpsen Industry-sponsored
Locations60 sites (Los Angeles, California and 59 other locations)
Trial IDNCT07435428 on ClinicalTrials.gov

What this trial studies

This Phase 3 study randomizes adults with moderate to severe glabellar lines to receive a single dose of IPN10200 or placebo in a double-blind phase, followed by an open-label phase where eligible participants may receive repeat doses of IPN10200. The protocol includes a screening period (up to 20 days) and one or more treatment cycles depending on response and eligibility. Outcomes include wrinkle severity rated by investigators and participants and safety/tolerability monitoring over time. The trial is conducted at aesthetic/ophthalmology clinic sites in California.

Who should consider this trial

Good fit: Adults aged 18 or older with moderate to severe glabellar (frown) lines who are dissatisfied with their appearance and can comply with study visits and requirements are ideal candidates.

Not a fit: People with only mild glabellar lines, certain medical contraindications, pregnancy, or inability to meet visit or contraception requirements may not benefit or be eligible.

Why it matters

Potential benefit: If successful, IPN10200 could provide a safe and effective option to reduce frown lines and improve appearance and confidence for adults with moderate to severe glabellar lines.

How similar studies have performed: Other injectable neuromodulators (botulinum toxin products) have a well-established record of success for treating glabellar lines, so this approach builds on an established treatment class.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 or legally adopted.

Exclusion Criteria:

* 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 interfere with evaluations.
* 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 washout period of at least five half lives might be required, as deemed appropriate by the investigator for long-acting medications.
* 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 discretion of the investigator.
* 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 prior to baseline.
* 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 interventional technique used) or chemical peel within the past 12 months prior to baseline.
* 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 study.
* 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 efficacy of the study intervention. Therapy considered necessary for the participant's welfare may be given at the discretion of the investigator. Note: If the permissibility of a specific medication/treatment is in question, the medical monitor will be contacted.
* 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 unknown within 30 days prior to the start of the study (prior to baseline) and during the conduct of the study.
* 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.

Where this trial is running

Los Angeles, California and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate to Severe Glabellar Lines
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.