CelluJuve® for the Treatment of Moderate to Severe NLFs

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

Study Overview

• Status: Recruiting
• Conditions: Nasolabial Fold Wrinkles
• Intervention / Treatment: Device: CelluJuve®

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serpil Kucuktepe, PhD; Phone Number: 1-866-384-4221; Email: skucuktepe@ethicaclinical.com

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • Skin Research Institute LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. 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.
2. 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.
3. Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
4. Able to follow study instructions and complete all required visits.
5. Signed ICF, Photographic Release, HIPAA, and if applicable the California Experimental Research Subject's Bill of Rights.

Exclusion Criteria

1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
2. A condition or situation that puts the subject at significant risk, may confound the study results, or may significantly interfere with subjects' study participation.
3. Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
4. 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.
5. 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).
6. Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
7. 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.
8. Herpes simplex lesion flare-ups greater than 6 per year.
9. 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.
10. 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.
11. Malignancy (excluding non-melanoma skin cancer) within the past 3 years.
12. 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.).
13. History or evidence of keloid scarring, susceptibility to keloid formation or hypertrophic scarring, or delayed healing activity.
14. 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.
15. History or presence of any autoimmune or connective tissue disease, receiving treatment with immunomodulating therapy, or is immunocompromised or immunosuppressed.
16. Known history of clinically significant skin pigmentation disorders.
17. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
18. Elective, clinically significant facial procedures that may confound the interpretation of the results in the NLF area (PI discretion), prior to study enrollment.
19. Physical attribute that may interfere with NLF assessment or treatment (e.g., facial hair, acne scarring, etc.).
20. Received a COVID-19 vaccine within 2 weeks of study entry.
21. Undergoing, or planning to undergo, radiation or ultrasound therapy in the treatment area.
22. History of any previous injectable filler to the study treatment area.
23. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CelluJuve®; CelluJuve® injected into left and right NLF	Device: CelluJuve®; CelluJuve®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity Rating Scale	5-point static scale ranging from 1-Absent to 5-Extreme	2 months, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months

Collaborators and Investigators

• Sponsor: Spiderwort Biotechnologies Inc.
• Investigators: Study Director: Charles M Cuerrier, PhD, Spiderwort Biotechnologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Nasolabial Folds
• Other Study ID Numbers: SPDR-2023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes