Actively Recruiting
A Phase III Randomized, Double-blind Study to Evaluate the Safety and Efficacy of a Single Dose of IPN10200 Compared to Placebo in Adults With Moderate to Severe Glabellar Lines
Led by Ipsen · Updated on 2026-04-30
300
Participants Needed
23
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of IPN10200 compared to a placebo in improving the appearance of moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. These lines can become more noticeable with age or repeated facial expressions and may affect a person's appearance and confidence. This is a Phase III, multicenter, randomized, placebo-controlled study involving adult participants. Participants will receive a single injection of either IPN10200 or placebo into selected muscles on the first day of treatment. The study includes three periods: a screening period lasting up to 20 days to determine eligibility, a treatment period on Day 1 with the injection, and a follow-up period lasting 52 weeks to monitor participants' health. During follow-up, participants will have regular visits to the study center and one telephone call visit. Throughout the study, participants will undergo health assessments including blood sampling, physical examinations, clinical evaluations, and electrocardiograms (ECG). They will also complete questionnaires and keep a diary to track their progress. The primary outcome is the percentage of participants responding to treatment from baseline to week 4. Safety and satisfaction measures will be monitored up to one year. Participants may withdraw consent at any time, and the total study duration for each participant is up to 55 weeks.
CONDITIONS
Brief 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...
- Participant must be male or female, aged 18 years or older at the time of signing informed consent.
- Have moderate or severe glabellar lines at maximum frown based on validated photographic and categorical scales.
- Be dissatisfied or very dissatisfied with their lines as assessed by a satisfaction scale.
- Female participants must use contraception according to local regulations.
- Able to give 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 staff directly involved in the study, or an immediate family member of such personnel.
You will not qualify if you...
- Have 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 the past 5 years.
- History of facial nerve palsy.
- Marked facial asymmetry, ptosis, excessive dermatochalasis, deep scars, or thick sebaceous skin.
- Scars, piercings, or tattoos in or near the treatment area within 6 months that may affect evaluations.
- Medical conditions increasing risk with botulinum toxin exposure, such as myasthenia gravis or amyotrophic lateral sclerosis.
- Botulinum toxin treatment in any body area within 9 months before the study.
- Prior participation in an IPN10200 study.
- Use of medications affecting neuromuscular transmission or aminoglycoside antibiotics within 30 days before the study.
- Use of systemic retinoids within 30 days before the study and planned use during the study.
- Prior permanent or non-permanent facial fillers or aesthetic procedures in the upper face within specified timeframes.
- Planned cosmetic surgery or procedures during the study that may interfere with evaluations.
- Positive tests for hepatitis B, hepatitis C, or HIV/AIDS.
- Significant psychiatric disorders that may interfere with participation.
- Known allergy to botulinum toxin or IPN10200 ingredients.
- History of drug abuse.
- Uncontrolled systemic disease or medical condition that would be harmful for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose on Day 1
Participants receive a single dose of IPN10200 or placebo through injections into the muscles between the eyebrows.
1 treatment visit (in-person)
Duration - Up to 52 weeks (1 year)
Participants are monitored for safety and effectiveness of the treatment for up to 1 year after the injection.
Multiple follow-up visits over 1 year
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
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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