CelluJuve Injections for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of CelluJuve®, a new injectable treatment, by observing its effects when injected into the upper arm of healthy volunteers. Researchers seek to ensure the injection's safety and study the skin's response at a microscopic level. Participants should be healthy and free of skin issues or conditions that could affect the study's results. Volunteers must be comfortable receiving injections and undergoing a small skin biopsy (a tiny piece of skin taken for study). As an unphased study, this trial offers participants the opportunity to contribute to groundbreaking research on a novel treatment.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it mentions that participants must adhere to medication restrictions during the study. It's best to discuss your specific medications with the study team.
What prior data suggests that CelluJuve® is safe for healthy volunteers?
Research shows that the safety of CelluJuve® remains under study. This device is still in development and has not yet received approval from Health Canada or the U.S. Food and Drug Administration. As a result, its safety and effectiveness for people are not fully known. Health Canada has permitted trials to test CelluJuve®, indicating it has passed some basic safety checks. However, detailed information about potential side effects or how well people tolerate the treatment is not yet available. Since this trial is in the early stages, further information about its safety will be collected.12345
Why are researchers excited about this trial?
Unlike the standard of care for skin rejuvenation, which often includes topical creams and laser treatments, CelluJuve® is unique because it involves injections using a novel formulation. Researchers are excited about CelluJuve® because it potentially offers a more direct approach to rejuvenating skin by targeting deeper layers, which could lead to more noticeable and lasting results. Additionally, the injectable nature of CelluJuve® may allow for a more personalized treatment, focusing on specific areas that need improvement.
What evidence suggests that CelluJuve® injections could be effective?
Research shows that the effectiveness of CelluJuve® in people remains unknown. This treatment is currently being tested in the trial to assess its effectiveness and safety. The trial's main goal is to determine the effects of injecting CelluJuve® into the skin. No clear results or data are available yet on its efficacy. Current studies, including this trial, continue to explore its potential benefits and safety.12467
Are You a Good Fit for This Trial?
Healthy adults aged 30-65, with healthy skin on their non-dominant arm, can join this trial. Women must not be pregnant or breastfeeding and use reliable contraception. People are excluded if they have a history of severe allergies to CelluJuve® components, keloid scarring, significant health conditions that could affect the study or are taking certain medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive injections of CelluJuve® into the proximal medial aspect of the brachium
Biopsy and Analysis
Punch biopsies are taken at 2 weeks, 1 month, and 3 months for histological analysis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CelluJuve®
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spiderwort Biotechnologies Inc.
Lead Sponsor
ethica Clinical Research Inc.
Industry Sponsor