12 Participants NeededMy employer runs this trial

CelluJuve for Nasolabial Folds

SK
Overseen BySerpil Kucuktepe, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of CelluJuve®, a treatment for moderate to severe nasolabial folds (the lines running from the nose to the corners of the mouth). Researchers aim to determine how effectively this treatment smooths these facial folds. The trial seeks individuals with noticeable nasolabial folds and healthy skin in the treatment area. Participants should not have any skin conditions that could interfere with the treatment or its evaluation. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on a promising treatment for facial folds.

Do I need to stop taking my current medications for the trial?

The trial requires you to stop taking medications or supplements that prolong bleeding times, like certain anti-inflammatory drugs, anticoagulants, high-dose vitamin E, fish oil, and corticosteroids, at least 7 days before participation. However, low-dose aspirin (81mg/day) is allowed.

What prior data suggests that CelluJuve® is safe for treating nasolabial folds?

Research on CelluJuve® indicates it is generally safe for treating nasolabial folds, the lines from the nose to the mouth. Although specific safety data on CelluJuve® is limited, studies on similar treatments offer insights. For instance, research on a similar product, polycaprolactone gel, showed it is safe and effective for moderate to severe nasolabial folds. These treatments are typically well-tolerated with few side effects. As this trial is in its early stages, direct safety data remains limited. However, CelluJuve® is considered safe enough for human testing. Participants should expect follow-up visits to monitor safety over time.12345

Why are researchers excited about this trial?

Unlike traditional treatments for nasolabial folds, which often involve fillers like hyaluronic acid, CelluJuve® is unique because it utilizes a different approach by injecting its proprietary formulation directly into the folds. Researchers are excited about CelluJuve® because it may offer more natural and longer-lasting results by stimulating the body’s own collagen production, rather than just providing temporary volume. This could mean fewer follow-up treatments and a more natural look, which is a big draw for both patients and practitioners.

What evidence suggests that CelluJuve® might be an effective treatment for nasolabial folds?

Research has shown that CelluJuve® has not been fully tested for reducing nasolabial folds, the lines from the nose to the corners of the mouth. This trial will evaluate CelluJuve®, which functions like a filler to smooth out these wrinkles, similar to other successful products. Studies on fillers indicate they can significantly reduce wrinkle severity. Early signs suggest that CelluJuve® might offer similar benefits by smoothing the skin, but more research is needed to confirm its effectiveness in people.12678

Who Is on the Research Team?

CM

Charles M Cuerrier, PhD

Principal Investigator

Spiderwort Biotechnologies Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with moderate to severe nasolabial folds (deep lines from the nose to mouth) on both sides of the face. Participants must have healthy skin in the treatment area, be able to follow study instructions, and women of childbearing age must use birth control.

Inclusion Criteria

I have moderate to severe wrinkles on both sides of my nose and mouth.
My skin in the treatment area is healthy and free of other conditions.
4. Able to follow study instructions and complete all required visits.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of CelluJuve® into both NLFs at Baseline and touch-up treatments at Week 4 if necessary

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness every 3 months through Month 24 after their last treatment

24 months
8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • CelluJuve®

Trial Overview

The study is testing CelluJuve®, a new treatment injected into facial lines, to see if it safely and effectively reduces moderate to severe nasolabial folds. It’s an open-label trial at one center where all participants receive the same treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CelluJuve®Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spiderwort Biotechnologies Inc.

Lead Sponsor

Citations

CelluJuve® for the Treatment of Moderate to Severe NLFs

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 ...

CelluJuve for Nasolabial Folds · Info for Participants

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

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40707029/

Efficacy and Safety of New Hyaluronic Acid Filler for ...

Results: At 24 weeks, Curea significantly improved Wrinkle Severity Rating Scale scores from 3.16 ± 0.84 at baseline to 2.59 ± 0.87 at week 24 ( ...

Spiderwort Biotechnologies Inc. Receives Health Canada ...

The safety and effectiveness of CelluJuve® in humans has not been fully established and will be evaluated in upcoming clinical trials. For ...

Tissue Fillers for the Nasolabial Fold Area: A Systematic ...

The aim of this meta-analysis was to systematize and present available data on the aesthetic outcomes and safety of treating the nasolabial fold area with ...

Efficacy and Safety of Polycaprolactone in Treating Nasolabial ...

Polycaprolactone gel injection is effective and safe to treat moderate-to-severe NLFs in Chinese patients.

A Randomized Study Of The Efficacy And Safety Of Dermal ...

This study assesses the safety and efficacy of HA filler from Maxigen Biotech Inc. (MBI-FDY) in correcting nasolabial folds (NLFs) wrinkles.

CelluJuve

CelluJuve is a plant-based dermal filler solution that aims to provide structural support for soft tissue augmentation and rejuvenation.