← Back to all trials
Not Yet Recruiting
NCT07912814
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Conditions: Periorbital Hollowing, Skin Aging
Sex: All
Ages: 25 Years – 65 Years
Healthy volunteers: Yes
Enrollment: 30
Sponsor: PharmaResearch Co.,Ltd
Location: MX Clinic Bangsar Kuala Lumpur
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.
Eligibility Criteria
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 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.
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, autoimmune disease (e.g., lupus, scleroderma, dermatomyositis) or current use of immunosuppressive therapy.
* 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.
Source: ClinicalTrials.gov (NCT07912814). StuddyBuddy aggregates publicly available trial information.