BridgeMD
New treatment option for Nasolabial Fold Wrinkles
Official title CelluJuve® for the Treatment of Moderate to Severe NLFs
ClinicalTrials.gov ID: NCT07545980
What this study is testing
- What it's testing
- Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join 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 people of...
- 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...
- 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 likely can't join if
- Female people 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 people' study...
- 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...
- people with known prolonged bleeding times due to disease or anticoagulants (e.g., warfarin). If on a drug or supplement that prolongs bleeding times...
- Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
See the full eligibility criteria
Who can 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 people of childbearing potential must have a negative UPT at Visit 1 and practice a...
- 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.
What rules you out
- Female people 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 people' 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.
- people 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Coral Gables, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coral Gables, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.