Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001061325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
22/07/2026
Date registered
Help: Date registered
27/08/2026
Date last updated
Help: Date last updated
27/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
27/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
A Feasibility Clinical Investigation Evaluating the Safety and Tolerability of Functional Ligand–Hyaluronic Acid and Functional Ligand–Cross Linker (DASI) Delivered by Microneedling in Healthy Adults with Facial Wrinkles and Signs of Skin Aging
Additional trial identifiers [1] 317385 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Skin aging 342046 0
Condition category
Condition code
Skin 338136 338136 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 334177 0
Treatment: Devices
Intervention code [2] 334940 0
Treatment: Other
Description of the comparator or control
Participants will receive a vehicle control consisting of citrate buffer (25 mM citrate buffer containing 0.2% ethylenediaminetetraacetic acid [EDTA], pH 4.6). A total of 0.5 mL of the comparator solution will be applied to the contralateral cheek and delivered into the superficial dermis using a microneedling device with a needle depth of 0.75 mm.

The comparator treatment 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 treatment preparation, application procedures, and microneedling techniques 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 cheek will be divided into four quadrants, with approximately 0.125 mL applied per quadrant prior to 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 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.
Control group
Placebo

Outcomes
Primary outcome [1] 345527 0
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
Timepoint [1] 345527 0
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 [1] 462033 0
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
Timepoint [1] 462033 0
Day 1 post-treatment, Day 4 (72-hour follow-up call), Weeks 1, 3, 5, 6, 8, and 12 post treatment
Secondary outcome [2] 462034 0
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
Timepoint [2] 462034 0
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
Secondary outcome [3] 462035 0
Signs of ophthalmic vascular occlusion - composite outcome
Timepoint [3] 462035 0
Day 1 post-treatment, Day 4 (72-hour follow-up call), Weeks 1, 3, 5, 6, 8, and 12 post treatment
Secondary outcome [4] 462036 0
Local skin tolerance following treatment - composite outcome
Timepoint [4] 462036 0
Immediately post-treatment, 2 hours post-treatment, Weeks 1, 3, 5, 6, 8, and 12 post treatment
Secondary outcome [5] 462037 0
Participant-reported adverse effects on facial skin
Timepoint [5] 462037 0
Immediately post-treatment, 2 hours post-treatment, Weeks 1, 3, 5, 6, 8, and 12 post treatment
Secondary outcome [6] 462038 0
Change in facial wrinkle severity
Timepoint [6] 462038 0
Baseline (Day 1 pre-treatment), Weeks 1, 3, 5, 6, 8, and 12 post treatment
Secondary outcome [7] 462039 0
Participant satisfaction with facial skin appearance
Timepoint [7] 462039 0
Baseline pre treatment, Week 5, and Week 12 post treatment
Secondary outcome [8] 462040 0
Participant satisfaction with treatment outcome
Timepoint [8] 462040 0
Week 5 and Week 12 post treatment

Eligibility
Key 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).
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
31/05/2027
Actual
Date of last data collection
Anticipated
10/09/2027
Actual
Sample size
Target
69
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321959 0
Commercial sector/Industry
Name [1] 321959 0
Fount Bio Pty Ltd
Country [1] 321959 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fount Bio Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 325012 0
None
Name [1] 325012 0
Address [1] 325012 0
Country [1] 325012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320496 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 320496 0
Ethics committee country [1] 320496 0
Australia
Date submitted for ethics approval [1] 320496 0
25/05/2026
Approval date [1] 320496 0
14/07/2026
Ethics approval number [1] 320496 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150658 0
Dr John Frew
Address 150658 0
Skin & Cancer Foundation Australia - The Skin Hospital 121 Crown Street Darlinghurst NSW 2010
Country 150658 0
Australia
Phone 150658 0
+61 02 86512040
Fax 150658 0
Email 150658 0
[email protected]
Contact person for public queries
Name 150659 0
Darryl Davies
Address 150659 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 150659 0
Australia
Phone 150659 0
+61 1300 030 380
Fax 150659 0
Email 150659 0
[email protected]
Contact person for scientific queries
Name 150660 0
Darryl Davies
Address 150660 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 150660 0
Australia
Phone 150660 0
+61 1300 030 380
Fax 150660 0
Email 150660 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.