Periorbital HollowingNCT07912814
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
An observational study of Periorbital Hollowing and Skin Aging, run by PharmaResearch Co.,Ltd at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periorbital Hollowing, Skin Aging
- 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
- 7 Dec 2026to 30 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
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.
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.
- 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.
Who cannot join
- 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, autoimmune disease (e.g., lupus, scleroderma, dermatomyositis) or current use of immunosuppressive therapy.
Show all 10Show fewer
- Known hypersensitivity or allergy to the ingredients of the investigational device, DOT PN (Rejuran S).
- History of keloid formation, or hypertrophic scarring.
- Current use of anticoagulants (e.g., warfarin, heparin), an platelet 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.
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 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:
Read more
- 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.
- Conditions
- Periorbital Hollowing, Skin Aging
- 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)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Week 16
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.
Measured: Baseline (Week 0) and Week 16
Secondary outcomes (6)
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.
Measured: Baseline (Week 0), Week 20, and Week 24
Change From Baseline in Brow Height at Weeks 20 and 24
Mean change in brow height (mm) from baseline, measured by QuantifiCare 3D imaging.
Measured: Baseline (Week 0), Week 20, and Week 24
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.
Measured: Baseline (Week 0), Weeks 16, 20, and 24
Investigator-Assessed Global Aesthetic Improvement Scale (GAIS)
Aesthetic improvement assessed by the investigator using the 5-point GAIS.
Measured: Weeks 16, 20, and 24
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.
Measured: Weeks 16, 20, and 24
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.
Measured: Screening through 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 start7 Dec 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital HollowingStudies 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
- NCT07912814
- Sponsor's protocol ID
- PR-SEA-2026-001
- 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 Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
- ClinicalTrials.gov ID
- NCT07912814
- Acronym / sponsor ID
- PR-SEA-2026-001
- Conditions
- Periorbital Hollowing, Skin Aging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PharmaResearch Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Oct 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 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.
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
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 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.
- 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.
Key exclusion criteria (10 listed)
- 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.
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)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. | Device | – |
Primary outcome
Change From Baseline in Tear Trough Depth at Week 16
Time frame: Baseline (Week 0) and 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.
Change From Baseline in Brow Height at Week 16
Time frame: Baseline (Week 0) and Week 16
Mean change in brow height (mm) from baseline, measured by QuantifiCare 3D imaging. Week 16 is 4 weeks after the final treatment.
6 secondary outcomes
Change From Baseline in Tear Trough Depth at Weeks 20 and 24
Time frame: Baseline (Week 0), Week 20, and Week 24
Change From Baseline in Brow Height at Weeks 20 and 24
Time frame: Baseline (Week 0), Week 20, and Week 24
Change From Baseline in Periorbital Wrinkles, Pores, and Brown Spots
Time frame: Baseline (Week 0), Weeks 16, 20, and 24
Investigator-Assessed Global Aesthetic Improvement Scale (GAIS)
Time frame: Weeks 16, 20, and 24
FACE-Q Eye Module "Satisfaction With Eyes" Score
Time frame: Weeks 16, 20, and 24
Incidence and Severity of Adverse Events (AEs) and Adverse Device Effects (ADEs)
Time frame: Screening through 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.
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 Periorbital Hollowing and Skin Aging, 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 6 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 Tear Trough Depth at Week 16 (time frame: Baseline (Week 0) and Week 16). The study lists 2 primary outcomes in all. 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.