A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines

Last updated: April 29, 2025
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

IPN10200

Dysport

IPN10200 Placebo

Clinical Study ID

NCT04821089
D-FR-10200-002
2020-003746-36
  • Ages 18-65
  • Female

Study Summary

The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines.

This study will be conducted in three stages. The full study (including all stages) will have a maximum 547 participants. The protocol is currently approved up to stage 1, step 1 and stage 1/ step 2.

Stage 1 (phase Ib & II)

  • Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL)

  • Step 2 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport

Stage 2 (phase II)

  • An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL
    • forehead lines (FHL) or lateral canthal lines (LCL)

Stage 3 (phase II)

  • A safety and efficacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be 18 to 65 years of age inclusive, at the time of signing theinformed consent.

  2. Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessedby the ILA using a validated 4-point photographic scale.

  3. Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessedby the SSA using a validated 4-point categorical scale.

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

Exclusion

Exclusion Criteria:

  1. An active infection or other skin problems in the upper face including the GL, FHL,and LCL area (e.g. acute acne lesions or ulcers).

  2. A history of eyelid blepharoplasty or brow lift within the past 5 years

  3. A history of facial nerve palsy.

  4. Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, orthick sebaceous skin.

  5. 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.)

  6. Has COVID-19 illness or a know positive SARS-CoV-2 test, or the presence of anyother condition (e.g. neuromuscular disorder or other disorder that could interferewith neuromuscular function)

  7. Previous treatment with any BoNT serotype for Stage 1 / Step 1 or any recentreatment (within the past 6 months prior to baseline) with any BoNT serotype forStage 1 / Step 2.

  8. Any prior treatment with permanent fillers in the upper face including the GL, FHLand LCL area.

  9. Any prior treatment with long lasting dermal fillers in the upper face including theGL area within the past 3 years and/or skin abrasions/resurfacing (whatever theinterventional technic used) within the past 5 years, or photo rejuvenation orskin/vascular laser intervention within the 12 months prior to Baseline.

  10. Any planned facial cosmetic surgery during the study.

  11. Use of concomitant therapy which, in the investigator's opinion, would interferewith the evaluation of the safety or efficacy of the study intervention, includingmedications affecting bleeding disorders (e.g. antiplatelet agents and/oranticoagulants given for treatment or prevention of cardiovascular/cerebrovasculardiseases).

  12. Use of medications that affect neuromuscular transmission, such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases andaminoglycoside antibiotics, within the past 30 days prior to Baseline.

  13. 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 halflife is unknown within 30 daysprior to the start of the study (prior to Baseline) and during the conduct of thestudy.

  14. Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for humanimmunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.

  15. Clinically diagnosed significant anxiety disorder, or any other significantpsychiatric disorder (e.g. depression) that might interfere with the participant'sparticipation in the study

  16. An inability to substantially lessen GL and/or horizontal forehead rhytids even byphysically spreading them apart as determined by the investigator.

  17. Known allergy or hypersensitivity to BoNT or any excipients of IPN10200 orDusport/Azzalure, or allergy to cow's milk protein.

  18. A history of drug or alcohol abuse

  19. Pregnant women, nursing women, premenopausal women or women of childbearingpotential not willing to practice a highly effective form of contraception method

  20. Male participants who are not vasectomized and who have female partners ofchildbearing potential and are not willing to use condoms with spermicide throughoutstudy participation.

Study Design

Total Participants: 727
Treatment Group(s): 3
Primary Treatment: IPN10200
Phase: 1/2
Study Start date:
April 06, 2021
Estimated Completion Date:
March 05, 2027

Connect with a study center

  • MEDITI - Clinique Del Mar

    Antibes,
    France

    Active - Recruiting

  • Palais de Flore

    Lyon,
    France

    Active - Recruiting

  • Clinique de Chirurgie Esthétique Iéna

    Paris,
    France

    Active - Recruiting

  • CRS Clinical Research Services Berlin GMBH

    Berlin, 13353
    Germany

    Completed

  • Interdisciplinary Study Association

    Berlin,
    Germany

    Site Not Available

  • ROSENPARK RESEARCH GmbH

    Darmstadt,
    Germany

    Active - Recruiting

  • Privatpraxis Dr. Hilton & Partner

    Düsseldorf,
    Germany

    Active - Recruiting

  • Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft

    Hamburg,
    Germany

    Active - Recruiting

  • Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow

    Mahlow,
    Germany

    Active - Recruiting

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