Crows Feet Lines
Conditions
Interventions
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, appl
Sponsors
Kang Myungah
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public Contactcontact Clinical trial
ICON Clinical Research GK
Outcome results
None listed