Actively Recruiting
A Study to Assess the Effectiveness and Safety of IPN10200 in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Led by Ipsen · Updated on 2026-04-30
300
Participants Needed
23
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Effectiveness and Safety of IPN10200 in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be male or female aged 18 years or older at the time of consent.
- Have moderate or severe glabellar lines at maximum frown at baseline as assessed by validated scales.
- Be dissatisfied or very dissatisfied with their lines at baseline.
- Female participants must use contraception consistent with local regulations.
- Able to provide signed informed consent and comply with study requirements.
- Have the time and ability to complete the study and follow instructions.
- Not reside in an institution by administrative or court order.
- Not be a sponsor employee, clinical research personnel, or immediate family member of such personnel.
You will not qualify if you...
- Active infection or skin problems in the upper face including the glabellar area.
- History of eyelid blepharoplasty, brow lift, or other upper facial surgery within 5 years.
- History of facial nerve palsy.
- Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
- Scars, piercings, or tattoos near the treatment area within 6 months that could interfere with evaluations.
- Medical conditions increasing risk with botulinum toxin exposure (e.g., myasthenia gravis).
- Botulinum toxin treatment within 9 months prior to study or previous IPN10200 use.
- Use of medications affecting neuromuscular transmission or aminoglycoside antibiotics within 30 days prior to baseline.
- Use of systemic retinoids within 30 days prior to baseline and planned use during study.
- Prior permanent or non-permanent facial treatments in the upper face within specified time frames.
- Planned cosmetic or aesthetic procedures during the study that could interfere with evaluations.
- Past surgery in the upper facial lines area.
- Use of experimental drugs or devices within specified time frames.
- Known positive for hepatitis B, hepatitis C, HIV, or AIDS diagnosis.
- Significant psychiatric disorders interfering with participation.
- Inability to substantially lessen glabellar lines.
- Allergy or hypersensitivity to botulinum toxin or IPN10200 ingredients.
- History of chronic or recreational drug abuse.
- Uncontrolled systemic disease or significant medical condition harmful to participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Skin Wellness Dermatology - Homewood
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Advanced Research Associates
Glendale, Arizona, United States, 85308
Actively Recruiting
3
Avacare
Scottsdale, Arizona, United States, 85260
Not Yet Recruiting
4
Investigate MD, LLC
Scottsdale, Arizona, United States, 85260
Actively Recruiting
5
Ablon Skin Institute and Research Center
Manhattan Beach, California, United States, 90266
Actively Recruiting
6
Keith A. Marcus, MD Inc
Redondo Beach, California, United States, 90277
Actively Recruiting
7
West Dermatology
San Diego, California, United States, 92121
Not Yet Recruiting
8
Ava T. Shamban, M.D., Inc.
Santa Monica, California, United States, 90404
Actively Recruiting
9
Art of Skin MD
Solana Beach, California, United States, 92075
Actively Recruiting
10
Pacific Clinical Innovations Inc.
Vista, California, United States, 92083
Actively Recruiting
11
Skin Research Institute
Coral Gables, Florida, United States, 33146
Actively Recruiting
12
ICON Dermatology and Aesthetics
Bethesda, Maryland, United States, 20852
Actively Recruiting
13
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States, 29407
Not Yet Recruiting
14
Westlake Dermatology & Cosmetic Surgery - Westlake
Austin, Texas, United States, 78746-5059
Actively Recruiting
15
Dermatology and Laser Surgery Center
Houston, Texas, United States, 77004
Actively Recruiting
16
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
Actively Recruiting
17
SkinDC
Arlington, Virginia, United States, 22209
Actively Recruiting
18
Carruthers and Humphrey Cosmetic Medicine
Vancouver, British Columbia, Canada, V5Z 4E1
Actively Recruiting
19
Pacific Dermaesthetics Inc.
Vancouver, British Columbia, Canada, V6H4E1
Not Yet Recruiting
20
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada, L6J 7W5
Actively Recruiting
21
Sweat clinics of canada
Toronto, Ontario, Canada, M5R 3N8
Actively Recruiting
22
Bertucci MedSpa
Woodbridge, Ontario, Canada, L4L 8E2
Not Yet Recruiting
23
Centre de Recherche Dermatologique de Quebec
Québec, Quebec, Canada, G1V4X7
Not Yet Recruiting
Research Team
I
Ipsen Recruitment Enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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