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An open-label, multicenter, single arm study evaluating the efficacy and safety of PRM-001 in the treatment of Crows Feet Lines(CFLs)on the sides of eyes in Japanese subjects

An open-label, multicenter, single arm study evaluating the efficacy and safety of PRM-001 in the treatment of Crows Feet Lines(CFLs)on the sides of the eyes in Japanese subjects

Kang Myungah

PharmaResearch Co., Ltd.

77-19, Gwahakdanji-ro, Gangneung-si, Gangwon State, 25452, Korea

makang@pharmaresarch.com

Clinical trial contact

ICON Clinical Research GK

Kyutaromachi 4-chome 1-3, Chuo-ku, Osaka city, Osaka 541-0056, Japan

+81-6-4560-2001

Japan-Chiken@iconplc.com

Pending

June. 01, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Male or female subjects aged >=20 years at the time of consent
Subjects seeking treatment for crows feet lines (CFL) with LCL severity >=2 at rest on both sides
Subjects willing to discontinue prior dermatological treatments during the study period
Subjects capable of understanding the study and complying with study procedures
Subjects who provide written informed consent

Subjects who fall under any of the following:
History of anaphylaxis or severe allergic reactions
History of autoimmune disease or immunocompromised condition
Use of antithrombotics (except low-dose aspirin), anticoagulants, or NSAIDs within 2 weeks prior to screening
Use of topical medications containing corticosteroids, retinoids, etc. within 4 weeks prior to screening
Known hypersensitivity to lidocaine
Wrinkle or acne treatment within 6 months prior to screening
Excessive smoking, alcohol consumption, sun exposure, or strenuous exercise
Aesthetic procedures (e.g., fillers, laser, peeling, botulinum toxin) in the treatment area within 6 months prior to screening
CaHA treatment within 18 months prior to screening
Presence of permanent facial implants (e.g., silicone)
Untreated scars or scars near the treatment area
History of hypertrophic scars or keloids
Dermatological conditions or infections on the face
Liver dysfunction, coagulation disorders, or need for antithrombotic therapy
Severe systemic or psychiatric disorders
Ongoing drug abuse
Participation in another clinical study within 6 months prior to screening
Non-Japanese subjects
Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception
Any other subjects deemed unsuitable by the investigator

Both

Crows Feet Lines

PRM-001 would be injected to the intradermal layer of a CFL site with up to 1.0 mL of volume at an injection. The maximum application volume of PRM-001 is 1.0 mL per CFL on the sides of each eye, applied a total of 4 times (3 times at 2-week intervals after the first application), so the maximum application volume for wrinkles under both eyes is 4.0 mL per side (the application volume for each subject is at the PI/ Sub-Is discretion).

Efficacy endpoints
Primary Endpoint:
To confirm the achievement of the success criterion that the lower limit of the 95% confidence interval for the improvement rate of LCL severity at 12 weeks after the final administration of PRM-001 (Visit 8) exceeds the performance goal.
Safety assessment:
Injection related information, Adverse event, Laboratory test, Physical Examinations, Local tolerability assessments

Improvement rate from baseline in LCL severity assessed by IIAI at 2 and 4 weeks, and GAIS(by PI/Sub-I and subjects) and Subject Self-Assessment (SSA) at 2, 4, and 12 weeks after the final PRM-001 injection(Visits 6-8).

+81-45-722-8655

Mar. 12, 2026

No

none