New wrinkle injection shows promise in phase 3 trial
NCT ID NCT07427797
First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 6 times
Summary
This study tests a single injection of IPN10200, a botulinum toxin type A, to improve moderate to severe frown lines between the eyebrows. About 300 adults will receive either the active drug or a placebo. Researchers will check how well the lines improve over 52 weeks using doctor and patient ratings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IPN10200 (a botulinum toxin type A injection)
- What this could lead to
- If it works, this could provide a safe, effective option to temporarily reduce frown lines and improve appearance and confidence.
- What could go wrong
- This is a cosmetic treatment, not a cure. Results are temporary, and individual responses vary. Possible side effects include injection site reactions or temporary muscle weakness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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309 people
The number who actually took part.
- Started
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Feb 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant should be male or female, ≥18 years of age inclusive at the time of signing the ICF. * 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. * Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at baseline, as assessed by the SLS. * 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 the 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. * Presence of any scars, piercings or tattoos (including micro blading 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. * Any known medical condition that may put the participant at increased risk in regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.). * Administration of any BoNT (other than the study intervention on baseline visit) 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. * Participants who have received IPN10200 in a previous 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 are 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 non-permanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) 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 photo rejuvenation, 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 UFL 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 prior to baseline visit 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 visit) and during the conduct of the study. * Known positive for hepatitis B antigen, 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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266, United States
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Advanced Research Associates
Glendale, Arizona, 85308, United States
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Art of Skin MD
Solana Beach, California, 92075, United States
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Ava T. Shamban, M.D., Inc.
Santa Monica, California, 90404, United States
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Avacare
Scottsdale, Arizona, 85260, United States
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Bertucci MedSpa
Woodbridge, Ontario, L4L 8E2, Canada
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Carruthers and Humphrey Cosmetic Medicine
Vancouver, British Columbia, V5Z 4E1, Canada
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Centre de Recherche Dermatologique de Quebec
Québec, Quebec, G1V4X7, Canada
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Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
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Dermatology and Laser Surgery Center
Houston, Texas, 77004, United States
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ICON Dermatology and Aesthetics
Bethesda, Maryland, 20852, United States
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Institute of Cosmetic and Laser Surgery
Oakville, Ontario, L6J 7W5, Canada
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Investigate MD, LLC
Scottsdale, Arizona, 85260, United States
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Keith A. Marcus, MD Inc
Redondo Beach, California, 90277, United States
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Pacific Clinical Innovations Inc.
Vista, California, 92083, United States
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Pacific Dermaesthetics Inc.
Vancouver, British Columbia, V6H4E1, Canada
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Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
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Skin Research Institute
Coral Gables, Florida, 33146, United States
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Skin Wellness Dermatology - Homewood
Birmingham, Alabama, 35209, United States
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SkinDC
Arlington, Virginia, 22209, United States
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Sweat clinics of canada
Toronto, Ontario, M5R 3N8, Canada
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West Dermatology
San Diego, California, 92121, United States
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Westlake Dermatology & Cosmetic Surgery - Westlake
Austin, Texas, 78746-5059, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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