Corabotase: A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.
Placebo: A single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.
Study summary
The purpose of this study is to assess the effectiveness and safety of a single dose of Corabotase (also known as IPN10200) compared to placebo (double-blind phase) and how well and safely repeat doses of Corabotase 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 Corabotase 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 Corabotase 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 Corabotase or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of Corabotase . In the open-label phase (de novo participants), participants will receive Corabotase in the first cycle and eligible participants may receive additional cycles of Corabotase. 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
For North America: Percentage of participants responding to treatment — At week 4 Measured by the multi-component response of ≥2-grade improvement and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown.
ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."
SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."
For EU and ROW: Percentage of participants responding to treatment as measured by ≥2-grades improvement on the ILA at maximum frown — From baseline to week 4 ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."
Trial sites (60)
Facility
City
Region
Status
Rivkin Westside Aesthetics
Los Angeles
California
Not Yet Recruiting
Clinical Testing of Beverly Hills
Los Angeles
California
Recruiting
Eye Research Foundation
Newport Beach
California
Recruiting
Steve Yoelin MD Medical Associates Inc
Newport Beach
California
Recruiting
Skin and Beauty Center
Pasadena
California
Recruiting
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
San Diego
California
Not Yet Recruiting
Southern California Dermatology, Inc.
Santa Ana
California
Not Yet Recruiting
DMR Research, PLLC
Westport
Connecticut
Recruiting
Center for Dermatology and Dermatologic Surgery
Washington D.C.
District of Columbia
Not Yet Recruiting
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
Aventura
Florida
Recruiting
Weinkle Dermatology
Bradenton
Florida
Recruiting
Skin Research Institute
Coral Gables
Florida
Not Yet Recruiting
Miami Dermatology & Laser Research
Miami
Florida
Recruiting
Kavali Plastic Surgery and Skin Renewal Center
Atlanta
Georgia
Recruiting
DeNova Research
Chicago
Illinois
Recruiting
Chicago Cosmetic and Dermatologic Research
Chicago
Illinois
Recruiting
Advanced Dermatology, A Forefront Dermatology Practice
Lincolnshire
Illinois
Not Yet Recruiting
LASSI - Laser and Skin Surgery Center of Indiana
Indianapolis
Indiana
Recruiting
Coleman Center For Cosmetic Dermatologic Surgery
Metairie
Louisiana
Not Yet Recruiting
DelRicht Research
New Orleans
Louisiana
Recruiting
Etre, Cosmetic Dermatology and Laser Center
New Orleans
Louisiana
Recruiting
Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
Hunt Valley
Maryland
Recruiting
Lawrence J. Green, MD. LLC
Rockville
Maryland
Recruiting
SkinCare Physicians
Chestnut Hill
Massachusetts
Recruiting
Michigan Center for Research Company
Clarkston
Michigan
Recruiting
Skin Specialists PC dba Schlessinger MD
Omaha
Nebraska
Recruiting
StracSkin
Portsmouth
New Hampshire
Recruiting
Rejuva Center at Williams
Latham
New York
Recruiting
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco
New York
Recruiting
Luxurgery
New York
New York
Recruiting
Dr. Z. Paul Lorenc MD, Office Of
New York
New York
Recruiting
Skin Search Of Rochester, Inc.
Rochester
New York
Recruiting
Rochester Dermatologic Surgery, P.C.
Victor
New York
Not Yet Recruiting
Aesthetic Solutions P.A.
Chapel Hill
North Carolina
Recruiting
Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
Charlotte
North Carolina
Recruiting
Nash Research Group, LLC
Powell
Ohio
Recruiting
Oregon Dermatology and Research Center
Portland
Oregon
Recruiting
Paddington Testing Company
Philadelphia
Pennsylvania
Recruiting
Brian S. Biesman MD, PLLC
Nashville
Tennessee
Recruiting
Tennessee Clinical Research Center
Nashville
Tennessee
Recruiting
+ 20 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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