CelluJuve® for the Treatment of Moderate to Severe NLFs

NCT07545980 | Not Yet Recruiting FDA Device

• 1 other identifier: SPDR-2023-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs

Conditions

Nasolabial Fold Wrinkles

Keywords

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CelluJuve®

EXPERIMENTAL

CelluJuve® injected into left and right NLF

Device: CelluJuve®

Interventions

CelluJuve® DEVICE

CelluJuve®

CelluJuve®

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Spiderwort Biotechnologies Inc.: lead

Study Sites (1)

Skin Research Institute LLC

Coral Gables, Florida, 33146, United States

Location

Study Officials

• Charles M Cuerrier, PhD

  Spiderwort Biotechnologies Inc.

  STUDY DIRECTOR

Central Study Contacts

Serpil Kucuktepe, PhD

CONTACT

1-866-384-4221; skucuktepe@ethicaclinical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)