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

未提供0 个研究点目标入组 142 人开始时间: 待定

适应症

试验速览

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•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

发起方

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