New device aims to smooth wrinkles without surgery
NCT ID NCT07545980
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early study is testing a device called CelluJuve® to see if it can safely reduce moderate to severe nasolabial folds (the lines from nose to mouth). Twelve adults with deep smile lines will receive the treatment. The goal is to check if wrinkles improve and if the device is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CelluJuve® (a device)
- What this could lead to
- If it works, this could offer a new option for reducing deep smile lines without surgery.
- What could go wrong
- This is a very small, early proof-of-concept study with only 12 people. It may not show clear results or lead to a widely available treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
22 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Nasolabial fold wrinkles are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Skin Research Institute LLC
RECRUITINGCoral Gables, Florida, 33146, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.