To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III) (NCT06205797) | Clinical Trial Compass
RecruitingPhase 3
To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)
South Korea312 participantsStarted 2024-06-20
Plain-language summary
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines
Who can participate
Age range19 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 19 Years to 65 Years(Adult, Older Adult)
* 2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.
* Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.
Exclusion Criteria:
* Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
* History of bleeding disorder
* Infection, dermatological condition or scar at the treatment injection sites
* Subject who has marked facial asymmetry
* History of facial nerve palsy or eyebrow/eyelid ptosis
* History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas
* History of malignant tumor within 5 years (except for basal cell carcinoma
* Any disease and condition that, in the view of the investigator, would interfere with study participation
* History of alcohol or drug addiction
* Subject who has been treated with any botulinum toxin drug within 6 months
* Persons who have received the following drugs with systemic muscle relaxant action within 4 weeks of screening
* Subjects taking more than 1,000 IU/day of anticoagulants, antiplatelet agents, NSAIDs, or vitamin E within 7 days prior to administration of the investigational drug (excluding low-dose aspirin)
* A person who has received a retinoid series of medications during the following period as of the time of screening
* Subjects who have hyperse…
What they're measuring
1
Percentage of participants whose glabellar lines at maximal frown are improved