Skin AgingNCT07912879
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
An observational study of Skin Aging and Horizontal Neck Lines, run by PharmaResearch Co.,Ltd at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Skin Aging, Horizontal Neck Lines
- What is being tested?
- DOT PN (Rejuran S)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Nov 2026to 15 Sep 2027
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Voluntarily signs and dates the informed consent 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.
Who cannot join
- 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, autoimmune disease (e.g., lupus, scleroderma, dermatomyosi s) or current use of immunosuppressive therapy.
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- Known hypersensitivity or allergy to the ingredients of the investigational device DOT PN (Rejuran S)
- History of keloid forma on, or hypertrophic scarring.
- Current use of anticoagulants (e.g., warfarin, heparin), an platelet 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
About this study
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:
Read more
- 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.
- Conditions
- Skin Aging, Horizontal Neck Lines
- Being tested
- DOT PN (Rejuran S)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOT PN (Rejuran S)Device
Also called Rejuran S, Polynucleotide (PN)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Week 16
Secondary outcomes (5)
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.
Measured: Baseline (Week 0), Week 20, and Week 24
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.
Measured: Week 16, Week 20, and Week 24
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.
Measured: Week 16, Week 20, and Week 24
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.
Measured: From Screening through Week 24
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.
Measured: Baseline (Week 0), Week 16, Week 20, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- PharmaResearch Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912879
- Sponsor's protocol ID
- PR-SEA-2026-002
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
- ClinicalTrials.gov ID
- NCT07912879
- Acronym / sponsor ID
- PR-SEA-2026-002
- Conditions
- Skin Aging, Horizontal Neck Lines
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PharmaResearch Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Voluntarily signs and dates the informed consent 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOT PN (Rejuran S)Also: Rejuran S, Polynucleotide (PN)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. | Device | – |
Primary outcome
Change From Baseline in Horizontal Neck Wrinkle Depth at Week 16
Time frame: Baseline (Week 0) and 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.
5 secondary outcomes
Change From Baseline in Horizontal Neck Wrinkle Depth at Weeks 20 and 24
Time frame: Baseline (Week 0), Week 20, and Week 24
Investigator-Assessed Global Aesthetic Improvement Scale (GAIS) Score at Weeks 16, 20, and 24
Time frame: Week 16, Week 20, and Week 24
FACE-Q Appraisal of Neck Scale Score at Weeks 16, 20, and 24
Time frame: Week 16, Week 20, and Week 24
Incidence and Severity of Adverse Events (AEs) and Adverse Device Effects (ADEs)
Time frame: From Screening through Week 24
Change From Baseline in Horizontal Neck Wrinkle Severity (HNWS) Grade at Weeks 16, 20, and 24
Time frame: Baseline (Week 0), Week 16, Week 20, and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Aging and Horizontal Neck Lines, run by PharmaResearch Co.,Ltd at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia, Singapore, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GLOBAL MEDICAL AFFAIRS PHARMARESEARCH (+82 31-696-3688, GlobalMA@pharmaresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Horizontal Neck Wrinkle Depth at Week 16 (time frame: Baseline (Week 0) and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.