Nasolabial Fold WrinklesNCT07545980
CelluJuve® for the Treatment of Moderate to Severe NLFs
A study testing CelluJuve® in people with Nasolabial Fold Wrinkles, run by Spiderwort Biotechnologies Inc. at 1 site in United States.
Trial summary
Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Nasolabial Fold Wrinkles
- What is being tested?
- CelluJuve®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 31 Jul 2028
- Phase
- Interventional
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race, 22 years of age or older, who are seeking therapy for correction of moderate to severe NLFs. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
- Moderate to severe bilateral NLFs with a severity grading of 3 or 4 as per the Wrinkle Severity Rating Scale (WSRS). Each NLF must have the same WSRS grade.
- Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
- Able to follow study instructions and complete all required visits.
- Signed ICF, Photographic Release, HIPAA, and if applicable the California Experimental Research Subject's Bill of Rights.
Who cannot join
- Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
- A condition or situation that puts the subject at significant risk, may confound the study results, or may significantly interfere with subjects' study participation.
- Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
- Abnormal visual tests (i.e., Snellen acuity test worse than 20/40 with corrections, if applicable), abnormal confrontational visual field test, and/or abnormal ocular motility test.
- Subjects with known prolonged bleeding times due to disease or anticoagulants (e.g., warfarin). If on a drug or supplement that prolongs bleeding times (e.g., non-steroidal anti-inflammatory, anticoagulant, high-dose vitamin E, fish oil, corticosteroids), wait 7 days or until bleeding times return to normal before injecting. (Note: low dose 81mg/day ASA is permitted).
- Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
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- Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to study treatment, or require interfering topical, systemic or surgical therapy.
- Herpes simplex lesion flare-ups greater than 6 per year.
- Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with interpretation of study results or compliance of the subject and could make the subject inappropriate for study entry.
- Known history of allergic/anaphylactic reactions to any of the components of CelluJuve® including known sensitivity to cellulose or local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- Malignancy (excluding non-melanoma skin cancer) within the past 3 years.
- History of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegener's disease, TB, etc.) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.).
- History or evidence of keloid scarring, susceptibility to keloid formation or hypertrophic scarring, or delayed healing activity.
- History or presence of severe chronic systemic diseases, including but not limited to, poorly controlled diabetes mellitus (all types), congestive heart failure, severe liver disease, severe kidney disease, and others as judged by the Investigator.
- History or presence of any autoimmune or connective tissue disease, receiving treatment with immunomodulating therapy, or is immunocompromised or immunosuppressed.
- Known history of clinically significant skin pigmentation disorders.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- Elective, clinically significant facial procedures that may confound the interpretation of the results in the NLF area (PI discretion), prior to study enrollment.
- Physical attribute that may interfere with NLF assessment or treatment (e.g., facial hair, acne scarring, etc.).
- Received a COVID-19 vaccine within 2 weeks of study entry.
- Undergoing, or planning to undergo, radiation or ultrasound therapy in the treatment area.
- History of any previous injectable filler to the study treatment area.
- Exposure to any other investigational drug/device within 90 days of study entry or planning to participate in another investigation during the course of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Skin Research Institute LLC
Coral Gables, Florida, 33146
About this study
Official title: Open-Label Proof-of-Concept Study of CelluJuve® for the Treatment of Moderate to Severe Nasolabial Folds
Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs
Read the detailed description
All subjects will receive injections of CelluJuve® into both NLFs at Visit 1 (Baseline) and will receive touch-up treatments (if necessary) at Week 4 (Visit 2).
Subjects will then be followed for 24 months after their last treatment (Visit 1 or Visit 2). Follow-up visits will occur every 3 months to collect safety and effectiveness data continuing through Month 24. The study will terminate after completion of the Month 24 visit.
At each study visit, safety will be assessed through adverse event reporting and injection sites will be assessed for the common treatment responses (CTRs) that typically occur following the injection of a dermal filler (i.e., erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration).
Blood sampling will be performed for safety laboratory testing and immunogenicity testing. Photography of the NLFs will be conducted at each visit. High-resolution cutaneous ultrasound of injection sites will be performed at select visits and prior to study exit.
At least 3 subjects will be of Fitzpatrick skin type IV to VI, with at least 1 subject will be of skin type V-VI.
- Conditions
- Nasolabial Fold Wrinkles
- Being tested
- CelluJuve®
- Keywords
- Nasolabial Folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelluJuve®Device
CelluJuve®
| Study group | Role | What they receive |
|---|---|---|
| CelluJuve® | Experimental | CelluJuve® injected into left and right NLF Receives: Device: CelluJuve® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Severity Rating Scale
5-point static scale ranging from 1-Absent to 5-Extreme
Measured: 2 months, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start29 Apr 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold WrinklesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spiderwort Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles M Cuerrier, PhD, Study director, Spiderwort Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545980
- Sponsor's protocol ID
- SPDR-2023-001
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) collected in this study will not be shared with other researchers. This is an early-stage, single-center, proof-of-concept clinical study of an investigational device with a small sample size, and no plan has been established for external sharing of de-identified participant-level data.