A study in healthy adults with facial wrinkles to evaluate the safety and performance of DASI (Functional Ligand–Hyaluronic Acid and Functional Ligand–Cross Linker) applied to the skin with microneedling

INTERVENTION: Participants will receive the investigational medical device DASI, a two‐component formulation comprising Functional Ligand–Hyaluronic Acid (Fli‐HA; hyaluronic acid‐cyanobenzothiazole‐glycine [HA‐GlyCBT]) and Functional Ligand–Cross Linker (Fli‐CL; cysteine‐ethylene diamine‐cysteine [Cys‐EDA‐Cys]). DASI is prepared immediately prior to treatment by mixing Fli‐HA and Fli‐CL to form Functional Ligand–Hyaluronic Acid Cross‐Linked (Fli‐HAXL). A total of 0.5 mL of the resulting Fli‐HAXL formulation will be applied to one randomly assigned cheek and delivered into the superficial dermis using a SkinPen® microneedling device with a needle depth of 0.75 mm. The intervention will be delivered face‐to‐face in an individual treatment setting at specialist aesthetic research clinics in Australia by trained investigators and study staff with expertise in dermal filler procedures, facial anatomy, and the detection and management of vascular occlusion events. Dedicated site training on DASI preparation, application, and microneedling procedures will be provided prior to study initiation. Treatment will be administered during two onsite clinic visits (Day 1 and Week 5). During each treatment session, the treated cheek will be divided into four quadrants, with approximately 0.125 mL of DASI (prepared as Fli‐HAXL) applied to each quadrant immediately before microneedling. Each quadrant will undergo circular microneedling passes for approximately 30 seconds, repeated three times. Participants will attend scheduled follow‐up visits and telephone assessments over a 12‐week period following the initial treatment and retreatment. Adherence will be ensured through direct onsite administration by study staff, electronic case report form documentation, participant vascular event diaries, scheduled follow‐up visits, and reminder telephone calls. CONDITION: Skin ‐ Other skin conditions Skin aging; ; Skin aging PRIMARY OUTCOME: Incidence and severity of adverse events related to Functional Ligand–Hyaluronic Acid Cross‐Linked delivered by microneedling in healthy adults with facial wrinkles and signs of skin aging ‐ Composite outcome[Assessment of adverse events including seriousness, severity, duration, and relationship to the investigational device or comparator, coded using the Medical Dictionary for Regulatory Activities and summarized by System Organ Class and Preferred Term From Day 1 treatment through Week 12 follow‐up, including assessments at Day 1 post‐treatment, Day 4 (72‐hour follow‐up call), Weeks 1, 3, 5, 6, 8, and 12 following initial treatment and retreatment at Week 5.] SECONDARY OUTCOME: Change in facial wrinkle severity[Modified Fitzpatrick Wrinkle Scale assessment by blinded investigators Baseline (Day 1 pre‐treatment), Weeks 1, 3, 5, 6, 8, and 12 post treatment] Local skin tolerance following treatment ‐ composite outcome[Investigator assessment of bruising, swelling, inflammation, granulomas, erythema, texture changes, and pigmentation changes using a 4‐point severity scale (none, mild, moderate, severe) Immediately post‐treatment, 2 hours post‐treatment, Weeks 1, 3, 5, 6, 8, and 12 post treatment] Participant satisfaction with facial skin appearance[Face‐Q Satisfaction with Skin questionnaire Baseline pre treatment, Week 5, and Week 12 post treatment] Participant satisfaction with treatment outcome[Face‐Q Satisfaction with Outcome questionnaire Week 5 and Week 12 post treatment] Participant‐reported adverse effects on facial skin[Face‐Q Adverse Effects: Skin questionnaire Immediately post‐treatment, 2 hours post‐treatment, Weeks 1, 3, 5, 6, 8, and 12 post treatment] Proportion of subjects with abnormal changes vs Day 1 in visual function according to Snellen best corrected visual acuity test, confrontational vision and ocular motility ‐ composite outcome[Snellen best corrected visual acuity testing, confrontational visual field testing, and ocular motility assessment Baseline (Screening to Day 1 pre‐treatment), post‐treatment to Week 1, Week 3 to Week 5 pre‐retreatment, post‐retreatment to Week 6, and Week 12] Proportion of subjects with signs of vascular occlusion specific to DASI‐treated and comparator‐treated side of the face over the duration of the investigation ‐ composite outcome[Clinical assessment of signs and symptoms of vascular occlusion including pain, blanching, swelling, skin discoloration, mottling, bruising, coolness, and changes in skin temperature Day 1 post‐treatment, Day 4 (72‐hour follow‐up call), Weeks 1, 3, 5, 6, 8, and 12 post treatment] Signs of ophthalmic vascular occlusion ‐ composite outcome[Clinical assessment for ocular pain, ptosis, ophthalmoplegia, diplopia, loss of vision, visual field defects, and necrosis around the eyes Day 1 post‐treatment, Day 4 (72‐hour follow‐up call), Weeks 1, 3, 5, 6, 8, and 12 post treatment] INCLUSION CRITERIA: 1. The subject is a female or a male adult aged 22 years or more. 2. The subject has a skin phototype I to VI on Fitzpatrick’s scale. 3. The subject has signs of skin aging such as rhytids, superficial facial wrinkles focusing on the cheek and midface areas, defined as grade 2 or 3 per Modified Fitzpatrick Wrinkle Scale (MFWS). 4. The subject can understand the verbal explanations and written information provided in local language and agrees to adhere to the requirements of the study. Also, the willingness and ability to give consent to participate in the study and provide a signed and dated informed consent to participate, as well as a Photo Consent form at the enrolment visit. 5. The subject is: a. A female of non‐childbearing potential (defined as post menopausal [i.e., absence of menstrual bleeding for 1 year prior to Day 1], hysterectomy, or bilateral oophorectomy); OR b. A female of childbearing potential who agrees to use an acceptable