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Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Sponsor: PharmaResearch Co.,Ltd
Summary
The goal of this clinical study is to evaluate changes in the appearance of horizontal neck lines after treatment with DOT PN (Rejuran S), a polynucleotide-based injectable medical device, administered using a dual-plane injection technique in adults aged 25 to 65 years with mild to moderate horizontal neck lines. The main question it aims to answer is: \- What is the mean change in horizontal neck wrinkle depth from the start of the study (Week 0) to Week 16, as measured by 3D imaging? All participants will receive the same study treatment; there is no comparison group. Participants will: * Receive DOT PN injections in the neck (4.0 mL per session) every 4 weeks, for a total of 4 sessions (Weeks 0, 4, 8, and 12) * Attend 7 study visits over 24 weeks for 3D imaging, wrinkle grading, questionnaires, and safety checks The injection technique, including the use of a blunt-tip cannula for the deeper layer, is a study-specific procedure defined by the study protocol and standardized across all study sites.
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2026-11-15
Completion Date
2027-09-15
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
DOT PN (Rejuran S)
Polynucleotide-based injectable medical device supplied in 1.0 mL prefilled syringes. Each session uses 4.0 mL in total (four 1.0 mL syringes), for 4 sessions at 4-week intervals (Weeks 0, 4, 8, and 12). Injections follow a study-specific dual-plane technique for horizontal neck lines: a superficial plane using a 30G sharp needle and a deeper plane using a 25G blunt-tip cannula introduced through a 23G guide needle. The cannula-based deeper-plane injection is a study-specific procedure and differs from the needle-based injection method described in the product's instructions for use.
Locations (3)
MX Clinic Bangsar
Kuala Lumpur, Malaysia
J Laser and Aesthetic Clinic
Singapore, Singapore
Dr. Atchima
Bangkok, Thailand