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Not yet recruitingNCT07912814Updated Nov 3, 2026

Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique

An observational study in Periorbital Hollowing and Skin Aging, sponsored by PharmaResearch Co.,Ltd. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 25 Years to 65 Years, including healthy volunteers. 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 learn whether DOT PN (Rejuran S), a polynucleotide injectable gel, improves periorbital hollowing (a sunken look around the eyes) in adults aged 25 to 65 years when injected into the deep layer around the eyes with a blunt cannula. Safety will also be assessed.

The main question it aims to answer is:

- How much do tear trough depth and brow height change from baseline to Week 16, as measured by 3D imaging?

There is no comparison group. All participants receive the study treatment.

Participants will:

  • Receive injections around both eyes (4.0 mL in total per visit) at Weeks 0, 4, 8, and 12
  • Have 3D facial photographs taken and report side effects at each visit
  • Return for follow-up visits at Weeks 16, 20, and 24.
02

Conditions studied

  • Periorbital Hollowing
  • Skin Aging
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
Yes
Sampling method
Non-probability sample

Study population

Adults aged 25 to 65 years with periorbital hollowing who are enrolled at 3 study sites in Thailand, Singapore, and Malaysia (approximately 10 participants per site, 30 in total) and who meet the protocol-defined eligibility criteria.

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.
  • Visible periorbital hollowing or deep fat volume loss confirmed on baseline imaging and clinical examina on by the investigator.
  • Fitzpatrick Skin Phototype I to V.
  • Willingness and ability to comply with all study procedures, visit schedules, and photographic requirements for the duration of the study.

Exclusion criteria

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Prior Periorbital Procedures.
  • Absolute Exclusion - History of any prior hyaluronic acid filler injection, or fat grafting in the periorbital area at any time in the past
  • 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 dermatitis, eczema, psoriasis) or infection (bacterial, viral, fungal) in the periorbital treatment area.
  • History of allergic diseases, sarcoid granulomatous pathology, Osler's endocarditis, disease (e.g., lupus, scleroderma, dermatomyositis) or current use of therapy.
  • Known or allergy to the ingredients of the device, DOT PN (Rejuran S).
  • History of keloid formation, or hypertrophic scarring.
  • Current use of anticoagulants (e.g., warfarin, heparin), an agents (e.g., aspirin, clopidogrel), or NSAIDs that cannot be discontinued 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)

    Sterile injectable gel containing 20 mg/mL sodium polynucleotide (1 mL pre-filled syringe). Injected into the periorbital deep (sub-SMAS) plane using a 25G blunt cannula (study-specific technique; the supplied 30G needle is not used), with entry points created by a 23G needle at three sites (ROOF, SOOF, and tear trough), using a linear retrograde and fanning technique. Dose: 2.0 mL per side (4.0 mL per session) at Weeks 0, 4, 8, and 12.

    Also known as: Rejuran S, Polynucleotide (PN)

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Tear Trough Depth at Week 16

    Mean change in tear trough depth (mm) from baseline, measured by QuantifiCare 3D imaging. Week 16 is 4 weeks after the final treatment.

    Time frame: Baseline (Week 0) and Week 16

  2. Change From Baseline in Brow Height at Week 16

    Mean change in brow height (mm) from baseline, measured by QuantifiCare 3D imaging. Week 16 is 4 weeks after the final treatment.

    Time frame: Baseline (Week 0) and Week 16

Secondary outcomes

  1. Change From Baseline in Tear Trough Depth at Weeks 20 and 24

    Mean change in tear trough depth (mm) from baseline, measured by QuantifiCare 3D imaging.

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

  2. Change From Baseline in Brow Height at Weeks 20 and 24

    Mean change in brow height (mm) from baseline, measured by QuantifiCare 3D imaging.

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

  3. Change From Baseline in Periorbital Wrinkles, Pores, and Brown Spots

    Mean change in periorbital wrinkles, pores, and brown spots from baseline, measured by the QuantifiCare 3D imaging Skincare Module.

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

  4. Investigator-Assessed Global Aesthetic Improvement Scale (GAIS)

    Aesthetic improvement assessed by the investigator using the 5-point GAIS.

    Time frame: Weeks 16, 20, and 24

  5. FACE-Q Eye Module "Satisfaction With Eyes" Score

    Subject-reported satisfaction with the appearance of the eyes, measured using the FACE-Q Eye Module "Satisfaction with Eyes" scale.

    Time frame: Weeks 16, 20, and 24

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

    Number of participants with AEs and ADEs, and their severity, reported throughout the study period.

    Time frame: Screening through 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

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 3, 2026
StartEst.
Dec 7, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Oct 30, 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT07912814
Lead sponsor
PharmaResearch Co.,Ltd
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Dec 7, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Oct 30, 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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