A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows

Last updated: April 29, 2026
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

IPN10200

Placebo

Clinical Study ID

NCT07435428
CLIN-10200-458
2025-522618-22-00
  • Ages 18-80
  • All Genders

Study Summary

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. They may affect a person's appearance and confidence.

All participants in the double-blind phase will receive IPN10200 or placebo during the first treatment cycle. De novo participants in the open-label phase will receive IPN10200 during the first treatment cycle. Some participants may receive additional treatment cycles with IPN10200 depending on their eligibility.

There will be 3 periods in this study:

  • A screening period (up to 20 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.

  • A treatment period where participants may receive up to 4 treatment cycles. In the double-blind phase, participants receive a single treatment of IPN10200 or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of IPN10200. In the open-label phase (de novo participants), participants will receive IPN10200 in the first cycle and eligible participants may receive additional cycles of IPN10200. Requires multiple visits during the first month followed by 1 visit every month.

  • A follow-up period (24 weeks) after the last injection where participants' health will be monitored.

Participants will undergo health measurements and observation, including blood sampling, physical examinations, clinical evaluations and electrocardiograms (ECG: recording of the electrical activity of heart). They will also be asked to fill in questionnaires and keep a diary.

Each participant will be in this study for up to 107 weeks. Participants may withdraw consent to participate at any time.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant should be male or female, ≥18 years of age at the time of signing theinformed consent.

  • Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA usinga validated 4-point photographic scale.

  • Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA usinga 4-point categorical scale.

  • Are 'dissatisfied' or 'very dissatisfied' with their GLs at baseline, as assessed bythe SLS score.

  • For female participants: Contraceptive use by women should be consistent with localregulations regarding the methods of contraception for those participating inclinical studies.

  • Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the ICF and in this protocol.

  • Participant has both the time and ability to complete the study and comply withstudy instructions.

  • Does not reside in an institution by administrative or court order.

  • Is not a sponsor employee or clinical research unit personnel directly affiliatedwith the study or is not an immediate family member. Immediate family is defined asa spouse, parent, child or sibling whether biological or legally adopted.

Exclusion

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 surgerywithin the past 5 years.

  • A history of facial nerve palsy.

  • Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring orthick 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 withregard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambertsyndrome, amyotrophic lateral sclerosis, etc.).

  • Presence of any scars, piercings, or tattoos (including microblading of theeyebrows) in or around the treatment area that have occurred within 6 months priorto baseline, or which in the investigator's opinion, could interfere withevaluations.

  • Administration of any BoNT (other than the study intervention) into any site of thebody and for any indication from 9 months prior to the first study visit until theend of the study.

  • Treatment with IPN10200 in any prior study.

  • Use of medications that affect neuromuscular transmission (such as curare-likenondepolarising agents, lincosamides, polymyxins, anticholinesterases) within thepast 30 days prior to baseline is prohibited or a longer washout period of at leastfive half lives might be required, as deemed appropriate by the investigator forlong-acting medications.

  • Use of aminoglycoside antibiotics within the past 30 days prior to baseline areprohibited. 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 useduring the study. Note: Topical retinoids are allowed other than in the areas thatwill be injected (upper facial area) at the discretion of the investigator.

  • Any prior treatment with permanent fillers, lifting threads, autologous fat orpermanent procedures in the upper face including the GL area.

  • Administration of any nonpermanent injectables (such as hyaluronic acid, calciumhydroxylapatite, poly-L-lactic acid or polymethyl-methacrylate) for soft tissueaugmentation therapy in the GL region within 12 months prior to baseline.

  • Any prior facial treatment or aesthetic procedures to the upper face includingphotorejuvenation, vascular or pigment laser or microneedling within the 3 monthsprior to baseline.

  • Any prior facial treatment or aesthetic procedures to the upper face involving skinresurfacing (including dermabrasion, laser, or whatever the interventional techniqueused) or chemical peel within the past 12 months prior to baseline.

  • Any planned cosmetic surgery or aesthetic procedures to the upper face during thestudy and/or any procedures to other parts of the face which in the investigator'sopinion, 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, wouldinterfere with the evaluation of the safety or efficacy of the study intervention.Therapy considered necessary for the participant's welfare may be given at thediscretion of the investigator. Note: If the permissibility of a specificmedication/treatment is in question, the medical monitor will be contacted.

  • Use of any experimental device within 30 days or use of any treatment with anexperimental drug within five times the documented terminal half-life of therespective drug or its metabolites or if the half-life is unknown within 30 daysprior to the start of the study (prior to baseline) and during the conduct of thestudy.

  • Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for humanimmunodeficiency virus or a diagnosis of acquired immunodeficiency syndrome.

  • Clinically diagnosed significant anxiety disorder, or any other significantpsychiatric disorder (e.g. depression) that might interfere with the participant'sparticipation 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 wouldbe harmful for the participant to be entered into the study or continueparticipation.

Study Design

Total Participants: 1300
Treatment Group(s): 2
Primary Treatment: IPN10200
Phase: 3
Study Start date:
February 18, 2026
Estimated Completion Date:
October 01, 2028

Connect with a study center

  • Sas Aimed

    Lyon, 69006
    France

    Site Not Available

  • Institut Cyrnos

    Nice, 6000
    France

    Site Not Available

  • Thinkin SAS

    Paris, 75016
    France

    Site Not Available

  • Rosenpark Research GmbH

    Darmstadt, 64283
    Germany

    Site Not Available

  • Privatpraxis Dr. Hilton & Partner

    Düsseldorf, 40212
    Germany

    Site Not Available

  • Derma Science GmbH

    Hamburg, 22609
    Germany

    Site Not Available

  • Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie

    Hamburg, 20146
    Germany

    Site Not Available

  • Noahklinik- Klinik fuer Plastische Chirurgie

    Kassel, 34117
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis

    Mahlow, 15831
    Germany

    Site Not Available

  • Skin Concept - Private Dermatology Practice

    München, 80333
    Germany

    Site Not Available

  • Haut- und Lasercentrum Potsdam

    Potsdam, 14467
    Germany

    Site Not Available

  • Akihabara Skin Clinic

    Chiyoda-ku, 101-0021
    Japan

    Active - Recruiting

  • Medical Corporation Chiseikai - Tokyo Center Clinic

    Chūōku, 103-0027
    Japan

    Active - Recruiting

  • Josui Dermatology Clinic

    Fukuoka, 810-0022
    Japan

    Active - Recruiting

  • Clinica BellaForma

    Minatoku, 107-0052
    Japan

    Active - Recruiting

  • Forest Palace Dermatology Clinic

    Nerima-ku, 177-0041
    Japan

    Active - Recruiting

  • Kume Derma Clinic

    Sakaishi, 593-8324
    Japan

    Active - Recruiting

  • Kotoni Tower Dermatology and Plastic Surgery

    Sapporo, 063-0812
    Japan

    Active - Recruiting

  • Yoshikawa Skin Clinic

    Takatsuki-shi, 569-0824
    Japan

    Active - Recruiting

  • Clinical Testing of Beverly Hills

    Los Angeles, California 91436
    United States

    Active - Recruiting

  • Rivkin Westside Aesthetics

    Los Angeles, California 90025
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Steve Yoelin MD Medical Associates Inc

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Skin and Beauty Center

    Pasadena, California 91105
    United States

    Active - Recruiting

  • Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.

    San Diego, California 92121
    United States

    Site Not Available

  • Southern California Dermatology, Inc.

    Santa Ana, California 92701
    United States

    Site Not Available

  • DMR Research, PLLC

    Westport, Connecticut 06880
    United States

    Active - Recruiting

  • Center for Dermatology and Dermatologic Surgery

    Washington D.C., District of Columbia 20037
    United States

    Site Not Available

  • Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Weinkle Dermatology

    Bradenton, Florida 34209
    United States

    Active - Recruiting

  • Skin Research Institute

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Miami Dermatology & Laser Research

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Kavali Plastic Surgery and Skin Renewal Center

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Chicago Cosmetic and Dermatologic Research

    Chicago, Illinois 60654-5826
    United States

    Active - Recruiting

  • DeNova Research

    Chicago, Illinois 60610
    United States

    Active - Recruiting

  • Advanced Dermatology, A Forefront Dermatology Practice

    Lincolnshire, Illinois 60069
    United States

    Site Not Available

  • LASSI - Laser and Skin Surgery Center of Indiana

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Coleman Center For Cosmetic Dermatologic Surgery

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Etre, Cosmetic Dermatology and Laser Center

    New Orleans, Louisiana 70130
    United States

    Active - Recruiting

  • Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)

    Hunt Valley, Maryland 21030
    United States

    Active - Recruiting

  • Lawrence J. Green, MD. LLC

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • SkinCare Physicians

    Chestnut Hill, Massachusetts 02467
    United States

    Active - Recruiting

  • Michigan Center for Research Company

    Clarkston, Michigan 48346
    United States

    Active - Recruiting

  • Skin Specialists PC dba Schlessinger MD

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • StracSkin

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Rejuva Center at Williams

    Latham, New York 12110
    United States

    Active - Recruiting

  • The Center for Dermatology, Cosmetic & Laser Surgery

    Mount Kisco, New York 10549
    United States

    Active - Recruiting

  • Dr. Z. Paul Lorenc MD, Office Of

    New York, New York 10028
    United States

    Active - Recruiting

  • Luxurgery

    New York, New York 10021
    United States

    Active - Recruiting

  • Skin Search Of Rochester, Inc.

    Rochester, New York 14623
    United States

    Active - Recruiting

  • Rochester Dermatologic Surgery, P.C.

    Victor, New York 14561
    United States

    Site Not Available

  • Aesthetic Solutions P.A.

    Chapel Hill, North Carolina 27517
    United States

    Active - Recruiting

  • Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Nash Research Group, LLC

    Powell, Ohio 43065
    United States

    Active - Recruiting

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Paddington Testing Company

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

  • Brian S. Biesman MD, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Clinical Research Center

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.