A Study to Assess the Effectiveness and Safety of IPN10200 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

Placebo

IPN10200

Clinical Study ID

NCT07427797
CLIN-10200-459
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to assess the effectiveness and safety of IPN10200 compared to placebo in the improvement of the appearance of moderate to severe glabellar lines in adult participants. 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.

In this study, all participants will receive a single injection of either IPN10200 or placebo (the study drug). 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 (Day 1) where all the eligible participants will receive a single injection of IPN10200 or placebo.

  • A follow-up period (52 weeks) where participants' health will be monitored, consisting of regular visits to the study centre and 1 telephone call visit.

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 55 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 inclusive at the time ofsigning the ICF.

  • 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.

  • Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at baseline, asassessed by the SLS.

  • 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 the 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.

  • Presence of any scars, piercings or tattoos (including micro blading 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.

  • Any known medical condition that may put the participant at increased risk in regardto 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 firststudy 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-likenondepolarising agents, lincosamides, polymyxins, anticholinesterases) within thepast 30 days prior to baseline are 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 non-permanent injectables (such as hyaluronic acid, calciumhydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) soft tissueaugmentation 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 priorto 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 UFL 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 prior to baseline visit or use of anytreatment with an experimental drug within five times the documented terminalhalf-life of the respective drug or its metabolites or if the half-life is unknownwithin 30 days prior to the start of the study (prior to baseline visit) and duringthe conduct of the study.

  • Known positive for hepatitis B antigen, 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: 300
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 27, 2026
Estimated Completion Date:
July 15, 2027

Connect with a study center

  • Carruthers and Humphrey Cosmetic Medicine

    Vancouver, British Columbia V5Z 4E1
    Canada

    Active - Recruiting

  • Pacific Dermaesthetics Inc.

    Vancouver, British Columbia V6H4E1
    Canada

    Site Not Available

  • Institute of Cosmetic and Laser Surgery

    Oakville, Ontario L6J 7W5
    Canada

    Active - Recruiting

  • Sweat clinics of canada

    Toronto, Ontario M5R 3N8
    Canada

    Active - Recruiting

  • Bertucci MedSpa

    Woodbridge, Ontario L4L 8E2
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique de Quebec

    Québec, Quebec G1V4X7
    Canada

    Site Not Available

  • Skin Wellness Dermatology - Homewood

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Advanced Research Associates

    Glendale, Arizona 85308
    United States

    Active - Recruiting

  • Avacare

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Investigate MD, LLC

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Ablon Skin Institute and Research Center

    Manhattan Beach, California 90266
    United States

    Active - Recruiting

  • Keith A. Marcus, MD Inc

    Redondo Beach, California 90277
    United States

    Active - Recruiting

  • West Dermatology

    San Diego, California 92121
    United States

    Site Not Available

  • Ava T. Shamban, M.D., Inc.

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Art of Skin MD

    Solana Beach, California 92075
    United States

    Active - Recruiting

  • Pacific Clinical Innovations Inc.

    Vista, California 92083
    United States

    Active - Recruiting

  • Skin Research Institute

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • ICON Dermatology and Aesthetics

    Bethesda, Maryland 20852
    United States

    Active - Recruiting

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Westlake Dermatology & Cosmetic Surgery - Westlake

    Austin, Texas 78746-5059
    United States

    Active - Recruiting

  • Dermatology and Laser Surgery Center

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • SkinDC

    Arlington, Virginia 22209
    United States

    Active - Recruiting

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.