None listed
Conditions
Brief summary
This study is investigating the safety and skin effects of a new hyaluronic acid-based treatment called Functional Ligand–Hyaluronic Acid Cross-Linked (Fli-HAXL) in healthy adults with facial wrinkles and signs of skin aging. The treatment is applied to the skin and delivered into the superficial layers of the skin using a microneedling device. Each participant will receive the investigational treatment on one cheek and a comparator vehicle treatment on the other cheek. The study aims to determine whether the investigational treatment is safe and well tolerated, with particular focus on skin reactions, vascular occlusion events, and visual symptoms. The study will also assess whether the treatment improves the appearance of facial wrinkles and participant satisfaction with their skin appearance. The hypothesis is that treatment with Functional Ligand–Hyaluronic Acid Cross-Linked delivered by microneedling will have a safety profile comparable to the comparator treatment while improving the appearance of facial wrinkles in adults with signs of skin aging.
Interventions
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 w
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.
Sponsors
Fount Bio Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Healthy volunteers
No
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 form of effective birth control for the duration of the study and is willing to take a Urine Pregnancy Test (UPT) at the screening/Day 1 visit and at the end of study visit. 6. The subject has a minimum visual acuity of 20/40 or better as measured by Snellen best corrected visual acuity test, satisfactory confrontational vision & no disturbance in ocular motility (confirmed with visual tests conducted by an experienced health professional).
Exclusion criteria
1. Presence of any disease or lesions near or on the area to be treated e.g. inflammation, active or chronic infection (on the face), facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex or zoster, viral conditions such as warts, cold sores, unhealed wounds or birthmarks, cancer or pre-cancer conditions such as actinic keratosis, or any physical attributes that may interfere with effectiveness assessments or study treatments, any skin lesions, scarring, tattoos, facial hairs (beard) or other issues. 2. The subject has experienced a facial flare of herpes virus infection in the last 5 years. 3. The subject had a facial active skin disease within the past 6 months or with a history of precancerous lesions or skin malignancies. 4. The subject has experienced excessive sun exposure or sunburn less than 1 month prior to the procedure. 5. The subject is a current smoker (or with substance abuse history). 6. The subject is ill health or has collagen vascular disease, significant systemic diseases (such as hepatitis or HIV (Human Immunodeficiency Virus)), immunological problems, or inflammatory skin conditions on the face. 7. The subject has an uncontrolled systemic disease or takes any significant systemic medication which is contraindicated in the opinion of the Investigator. 8. Subjects have received any topical retinoids or steroids within the past 3 months or systemic retinoids within 6 months and still under those treatments. 9. The subject has had a non-ablative and/or ablative laser procedure of the face in the past 6 months. 10. The subject has undergone any facial aesthetic treatments or implants including facial plastic surgery, thread lifting procedures or autologous fat injections, any permanent fillers, silicone-based implants or a semipermanent filler, e.g. PLLA (Poly-L-Lactic Acid), calcium hydroxyl apatite, during the past 24 months, any non-permanent fillers in the face during the past 12 months, or any neurotoxin injections in the face within the past 6 months or dermal resurfacing procedures, non-invasive skin tightening procedures within the past 2 years, or energy-based or mechanical/chemical aesthetic procedures on the face within the past 6 months 11. The subject has a known allergy to HA (Hyaluronic Acid). 12. Related to the use of the microneedling device, the subject: a. Has diabetes; b. Has an allergy to stainless steel or topical or local anesthetics, or has a history of contact dermatitis to these products; c. Is taking high doses of anti-coagulants or blood-thinning substances, e.g., acetylsalicylic acid (aspirin), warfarin, or heparin; d. Is currently being treated with or about to undergo treatments using chemotherapy, radiotherapy, or high dose corticosteroids; 13. The subject is currently enrolled in an investigational-drug or device study or has participated in such a study in the past 3 months and is still in the exclusion period. 14. The subject is an employee or relative of an employee of the clinical site or study sponsor. 15. The subject is vulnerable as defined in Section 3.55 of the ISO 14155:2020 standard for Good Clinical Practice (GCP). 16. The subject has received a COVID-19 vaccine within the past two weeks of the anticipated treatment visit.
Outcome results
None listed