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

  • STATUS
    Recruiting
  • End date
    Jul 15, 2022
  • participants needed
    56
  • sponsor
    Ipsen
Updated on 15 August 2021

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 424 participants. The protocol is currently approved up to stage 1, step 1.

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): does finding step in participants with moderate to severe GL

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 efficiacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)

Details
Condition Moderate to Severe Upper Facial Lines
Treatment IPN10200, IPN10200 Placebo
Clinical Study IdentifierNCT04821089
SponsorIpsen
Last Modified on15 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent
Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the ILA using a validated 4-point photographic scale
Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale
Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, as assessed by the SLS

Exclusion Criteria

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)
A history of eyelid blepharoplasty or brow lift within the past 5 years
A history of facial nerve palsy
Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin
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.)
Has COVID-19 illness or a positive SARS-CoV-2 test, or the presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function)
Previous treatment with any BoNT serotype
Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area
Any prior treatment with long lasting dermal fillers in the upper face including the GL area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the 12 months prior to Baseline
Any planned facial cosmetic surgery during the study
Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders (e.g. antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases)
Use of medications that affect neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days prior to Baseline
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 halflife 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 (HIV) 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 and/or horizontal forehead rhytids even by physically spreading them apart as determined by the investigator
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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