Restylane Injectables for Cosmetic Use
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different types of Restylane, a popular facial filler, distribute and remain in place after cosmetic injection. Researchers focus on how well these fillers integrate with facial tissues and whether they migrate from the original injection site. The trial suits individuals with noticeable facial volume loss or contour issues who haven't used facial fillers in the past 18 months. Participants must agree to follow the study's rules, including avoiding other facial procedures during the trial. As an unphased trial, this study allows participants to contribute to valuable research on facial fillers and their effects.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you should avoid certain treatments like blood thinners and NSAIDs (non-steroidal anti-inflammatory drugs) two weeks before treatment. It's best to discuss your specific medications with the trial team.
What prior data suggests that Restylane injectables are safe for cosmetic use?
Research has shown that Restylane injections are generally safe and have been used worldwide for over 20 years. U.S. studies have found these fillers safe for most people.
However, some risks exist. In rare cases, vision problems, including blindness, have occurred when fillers were injected into areas like the nose. Trained professionals should perform injections to help reduce these risks.
Overall, Restylane is usually safe when used correctly. Always consult a healthcare provider about possible side effects before treatment.12345Why are researchers excited about this trial?
Restylane injectables are unique because they utilize hyaluronic acid, a natural substance found in the body, to enhance facial volume and smooth out wrinkles. Unlike other treatments that might use synthetic fillers or require surgical intervention, Restylane offers a minimally invasive option with immediate results and minimal downtime. Researchers are excited about Restylane because its biocompatibility reduces the risk of adverse reactions, and its effects can be long-lasting, providing natural-looking improvements in facial aesthetics.
What is the effectiveness track record for Restylane injectables for cosmetic use?
Research has shown that Restylane fillers effectively refresh the face, add volume, and improve shape. For instance, one study found that 82% of participants saw an improvement in their appearance up to 9 months after receiving Restylane injections. Another study demonstrated that all participants using Restylane for cheek fillers perceived the results as natural. Restylane is also recognized for its safety and effectiveness, particularly in reducing smile lines. These fillers enhance facial features and create soft contours while maintaining natural expressions.16789
Who Is on the Research Team?
Andreas Nikolis, MD
Principal Investigator
Erevan Innovations Inc.
Are You a Good Fit for This Trial?
This trial is for individuals seeking facial rejuvenation through soft tissue filler injections. It's important that participants are looking for volume restoration or contour enhancement and have no health conditions that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pan-facial HA injections using NASHA and OBT-based products
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of filler migration and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Restylane
Trial Overview
The study is testing Restylane injectables, specifically comparing different types of hyaluronic acid-based fillers (NASHA vs. OBT) to see how they integrate into tissues and whether they tend to migrate from where they're injected over short to intermediate terms.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All adult participants (\>18 years)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Erevna Innovations Inc.
Lead Sponsor
Citations
Efficacy of a New Hyaluronic Acid Dermal Filler on ...
Improvement was maintained up to 9 months after injection with 82% of subjects reporting an improvement of their aesthetic appearance with ESTLF ...
Cheek Fillers Before and After Results
100%. of Restylane Lyft and Restylane Contour patients thought their cheek filler results looked natural. · 89%. of patients† thought they looked less tired ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
Based on the results of the. 43USTT1904 clinical study, Restylane Eyelight demonstrated a favorable safety and effectiveness profile for injection with needle ...
Full article: A 52-week follow-up, multi-center, randomized, ...
Previous studies have established that Restylane is a safe and effective HA dermal filler for the correction of NLFs. However, there is a ...
Restylane® Dermal Fillers - Galderma Aesthetics
Restylane® goes beyond just volumizing the face. Get everything from enhanced facial structure, soft contours that maintain your natural expressions and a ...
Resources and Information for Healthcare Professionals
Important Safety Information ... The Restylane® family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane®-L, Restylane ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
Vision abnormalities including blindness have been reported following injection of dermal fillers including HA, with and without lidocaine, into the nose, ...
Restylane: Uses, Dosage, Side Effects
Important Safety Information · Based on U.S. clinical studies, patients should be limited to 6 mL per patient per treatment in wrinkles and folds ...
Galderma receives U.S. FDA approval for Restylane® Lyft ...
Restylane Lyft is a versatile HA injectable with over 20 years of worldwide safety data, which is also approved to treat the midface, facial ...
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