Restylane Injectables for Cosmetic Use

Overseen By Laura Raco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erevna Innovations Inc.

Must not be taking: NSAIDs, Anticoagulants, Immunosuppressants, others

Disqualifiers: Pregnancy, Liver diseases, Heavy smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: Baseline to Week 24

10 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

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

I am using a reliable method of birth control as required.

I can attend all scheduled follow-up visits.

I am 18 years old or older.

Exclusion Criteria

I haven't had tissue therapy in the treatment area in the last 6 months.

History of severe or multiple allergies manifested by anaphylaxis

I have a disease that is not currently under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pan-facial HA injections using NASHA and OBT-based products

Baseline to Week 24

Visits at Baseline, Week 12, and Week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of filler migration and adverse events

4 weeks

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?

Group I: Restylane Injectables Experimental Treatment 1 Intervention

All adult participants (\>18 years)

Who Is Running the Clinical Trial?

Erevna Innovations Inc.

Lead Sponsor

Trials

13

Recruited

340+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11288387/

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 ...

2. restylaneusa.com restylaneusa.com/treatment-area/cheeks

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 ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf4/P040024S135B.pdf

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 ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/09546634.2024.2378165

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 ...

5. galdermaaesthetics.com galdermaaesthetics.com/restylane-dermal-fillers

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 ...

6. restylaneusa.com restylaneusa.com/hcp

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 ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/p140029b.pdf

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, ...

8. drugs.com drugs.com/restylane.html

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 ...

9. galderma.com galderma.com/news/galderma-receives-us-fda-approval-restylane-lyft

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 ...