New wrinkle treatment aims to smooth frown lines in large trial

NCT ID NCT07435428

Symptom relief Sponsor: Ipsen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This phase 3 study tests an injection called IPN10200 for moderate to severe frown lines (the wrinkles between your eyebrows). About 1,300 adults will receive either the active treatment or a placebo, and some may get up to 4 treatment cycles over nearly two years. The goal is to see if the injection safely reduces the appearance of these lines and improves how people feel about their look.

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 and effective option to reduce frown lines, improving appearance and confidence.
What could go wrong: This is a cosmetic treatment, not a medical necessity. Results may vary, and repeat injections are needed to maintain effect. Side effects like bruising or temporary muscle weakness are possible.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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 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.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

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.

Moderate to severe glabellar lines

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

60 sites in 4 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Advanced Dermatology, A Forefront Dermatology Practice
NOT_YET_RECRUITING

Lincolnshire, Illinois, 60069, United States
Aesthetic Solutions P.A.
RECRUITING

Chapel Hill, North Carolina, 27517, United States
Akihabara Skin Clinic
RECRUITING

Chiyoda-ku, 101-0021, Japan
Brian S. Biesman MD, PLLC
RECRUITING

Nashville, Tennessee, 37203, United States
Center for Clinical Studies
NOT_YET_RECRUITING

Webster, Texas, 77598, United States
Center for Dermatology and Dermatologic Surgery
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20037, United States
Chicago Cosmetic and Dermatologic Research
RECRUITING

Chicago, Illinois, 60654-5826, United States
Clinica BellaForma
RECRUITING

Minatoku, 107-0052, Japan
Clinical Testing of Beverly Hills
RECRUITING

Los Angeles, California, 91436, United States
Coleman Center For Cosmetic Dermatologic Surgery
NOT_YET_RECRUITING

Metairie, Louisiana, 70006, United States
DMR Research, PLLC
RECRUITING

Westport, Connecticut, 06880, United States
DeNova Research
RECRUITING

Chicago, Illinois, 60610, United States
DelRicht Research
RECRUITING

New Orleans, Louisiana, 70115, United States
Derma Science GmbH
NOT_YET_RECRUITING

Hamburg, 22609, Germany
Dermatologische Gemeinschaftspraxis
NOT_YET_RECRUITING

Mahlow, 15831, Germany
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
NOT_YET_RECRUITING

San Diego, California, 92121, United States
Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
RECRUITING

Charlotte, North Carolina, 28207, United States
Dr. Z. Paul Lorenc MD, Office Of
RECRUITING

New York, New York, 10028, United States
Etre, Cosmetic Dermatology and Laser Center
RECRUITING

New Orleans, Louisiana, 70130, United States
Eye Research Foundation
RECRUITING

Newport Beach, California, 92663, United States
Forest Palace Dermatology Clinic
RECRUITING

Nerima-ku, 177-0041, Japan
Haut- und Lasercentrum Potsdam
NOT_YET_RECRUITING

Potsdam, 14467, Germany
Institut Cyrnos
NOT_YET_RECRUITING

Nice, 6000, France
Josui Dermatology Clinic
RECRUITING

Fukuoka, 810-0022, Japan
Kavali Plastic Surgery and Skin Renewal Center
RECRUITING

Atlanta, Georgia, 30328, United States
Kotoni Tower Dermatology and Plastic Surgery
RECRUITING

Sapporo, 063-0812, Japan
Kume Derma Clinic
RECRUITING

Sakaishi, 593-8324, Japan
LASSI - Laser and Skin Surgery Center of Indiana
RECRUITING

Indianapolis, Indiana, 46260, United States
Lawrence J. Green, MD. LLC
RECRUITING

Rockville, Maryland, 20850, United States
Luxurgery
RECRUITING

New York, New York, 10021, United States
Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
RECRUITING

Hunt Valley, Maryland, 21030, United States
Medical Corporation Chiseikai - Tokyo Center Clinic
RECRUITING

Chūōku, 103-0027, Japan
Miami Dermatology & Laser Research
RECRUITING

Miami, Florida, 33133, United States
Michigan Center for Research Company
RECRUITING

Clarkston, Michigan, 48346, United States
Nash Research Group, LLC
RECRUITING

Powell, Ohio, 43065, United States
Noahklinik- Klinik fuer Plastische Chirurgie
NOT_YET_RECRUITING

Kassel, 34117, Germany
Oregon Dermatology and Research Center
RECRUITING

Portland, Oregon, 97210, United States
Paddington Testing Company
RECRUITING

Philadelphia, Pennsylvania, 19103, United States
Privatpraxis Dr. Hilton & Partner
NOT_YET_RECRUITING

Düsseldorf, 40212, Germany
Rejuva Center at Williams
RECRUITING

Latham, New York, 12110, United States
Rivkin Westside Aesthetics
NOT_YET_RECRUITING

Los Angeles, California, 90025, United States
Rochester Dermatologic Surgery, P.C.
NOT_YET_RECRUITING

Victor, New York, 14561, United States
Rosenpark Research GmbH
NOT_YET_RECRUITING

Darmstadt, 64283, Germany
Sas Aimed
NOT_YET_RECRUITING

Lyon, 69006, France
Skin Concept - Private Dermatology Practice
NOT_YET_RECRUITING

München, 80333, Germany
Skin Research Institute
NOT_YET_RECRUITING

Coral Gables, Florida, 33146, United States
Skin Search Of Rochester, Inc.
RECRUITING

Rochester, New York, 14623, United States
Skin Specialists PC dba Schlessinger MD
RECRUITING

Omaha, Nebraska, 68144, United States
Skin and Beauty Center
RECRUITING

Pasadena, California, 91105, United States
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
RECRUITING

Aventura, Florida, 33180, United States
SkinCare Physicians
RECRUITING

Chestnut Hill, Massachusetts, 02467, United States
Southern California Dermatology, Inc.
NOT_YET_RECRUITING

Santa Ana, California, 92701, United States
Steve Yoelin MD Medical Associates Inc
RECRUITING

Newport Beach, California, 92663, United States
StracSkin
RECRUITING

Portsmouth, New Hampshire, 03801, United States
Tennessee Clinical Research Center
RECRUITING

Nashville, Tennessee, 37215, United States
The Center for Dermatology, Cosmetic & Laser Surgery
RECRUITING

Mount Kisco, New York, 10549, United States
Thinkin SAS
NOT_YET_RECRUITING

Paris, 75016, France
Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie
NOT_YET_RECRUITING

Hamburg, 20146, Germany
Weinkle Dermatology
RECRUITING

Bradenton, Florida, 34209, United States
Yoshikawa Skin Clinic
RECRUITING

Takatsuki-shi, 569-0824, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.