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Not yet recruitingNCT07912879Updated Nov 3, 2026

Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)

An observational study in Skin Aging and Horizontal Neck Lines, sponsored by PharmaResearch Co.,Ltd. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by PharmaResearch Co.,Ltd · Observational

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Aging
  • Horizontal Neck Lines
03

In context

Lead sponsor

PharmaResearch Co.,Ltd is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults aged 25 to 65 years with horizontal neck lines graded 1 to 3 on the Horizontal Neck Wrinkle Severity (HNWS) scale, enrolled at the participating study sites in Thailand, Singapore, and Malaysia.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Voluntarily signs and dates the form (ICF) prior to any study-related procedures.
  • Male or female adults aged 25 to 65 years at the time of screening.
  • Presence of visible horizontal neck wrinkles, specifically graded as HNWS grade 1 to 3 (mild to moderate neck lines), confirmed on baseline imaging and clinical examination by the investigator.
  • Willingness and ability to comply with all study procedures, visit schedules, and photographic requirements for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  • Prior Procedures.
  • Absolute Exclusion - History of any prior hyaluronic acid filler injection, or fat grafting in the neck area at any time in the past.
  • Temporary Exclusion - History of botulinum toxin or energy-based device (EBD) treatments (e.g., focused ultrasound, radiofrequency, lasers) in the neck area within 6 months prior to screening.
  • Female subjects who are pregnant or breastfeeding.
  • Presence of damaged skin (e.g., areas affected by inflammation or infection), active skin disease (e.g., contact derma s, eczema, psoriasis) or infection (bacterial, viral, fungal) in the treatment area.
  • History of allergic diseases, sarcoid granulomatous pathology, Osler's endocarditis, disease (e.g., lupus, scleroderma, dermatomyosi s) or current use of therapy.
  • Known or allergy to the ingredients of the device DOT PN (Rejuran S)
  • History of keloid forma on, or hypertrophic scarring.
  • Current use of anticoagulants (e.g., warfarin, heparin), an agents (e.g., aspirin, clopidogrel), or NSAIDs that cannot be discon nued at least 7 days prior to injection, or a known history of bleeding disorders.
  • Any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study or compromise the safety or validity of the study results.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
24 Weeks
Patient registry
Yes

Interventions

  • DeviceDOT 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.

    Also known as: Rejuran S, Polynucleotide (PN)

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Horizontal Neck Wrinkle Depth at Week 16

    Mean change in horizontal neck wrinkle depth from Baseline (Week 0) to Week 16 (4 weeks after the final treatment session), measured by QuantifiCare 3D imaging.

    Time frame: Baseline (Week 0) and Week 16

Secondary outcomes

  1. Change From Baseline in Horizontal Neck Wrinkle Depth at Weeks 20 and 24

    Mean change in horizontal neck wrinkle depth from Baseline to Week 20 and Week 24, measured by QuantifiCare 3D imaging.

    Time frame: Baseline (Week 0), Week 20, and Week 24

  2. Investigator-Assessed Global Aesthetic Improvement Scale (GAIS) Score at Weeks 16, 20, and 24

    Global Aesthetic Improvement Scale (GAIS) score assessed by the Investigator using the GAIS 5-point scale at Week 16, Week 20, and Week 24.

    Time frame: Week 16, Week 20, and Week 24

  3. FACE-Q Appraisal of Neck Scale Score at Weeks 16, 20, and 24

    Participant-reported outcome measured using the FACE-Q Aesthetics Module scale at Week 16, Week 20, and Week 24.

    Time frame: Week 16, Week 20, and Week 24

  4. Incidence and Severity of Adverse Events (AEs) and Adverse Device Effects (ADEs)

    Incidence and severity of Adverse Events (AEs) and Adverse Device Effects (ADEs) reported throughout the study period, from Screening through Week 24.

    Time frame: From Screening through Week 24

  5. Change From Baseline in Horizontal Neck Wrinkle Severity (HNWS) Grade at Weeks 16, 20, and 24

    Change in Horizontal Neck Wrinkle Severity (HNWS) grade from Baseline (Week 0) to Week 16, Week 20, and Week 24, assessed by the Investigator.

    Time frame: Baseline (Week 0), Week 16, Week 20, and Week 24

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: No — There is currently no plan to make individual participant data (IPD) available to other researchers.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07912879
Lead sponsor
PharmaResearch Co.,Ltd
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
May 15, 2027 (estimated)
Completion
Sep 15, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

GLOBAL MEDICAL AFFAIRS PHARMARESEARCH
Contact
GlobalMA@pharmaresearch.com
+82 31-696-3688

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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