Nasolabial Folds

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2 Nasolabial Folds Trials Near You

Power is an online platform that helps thousands of Nasolabial Folds patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication
The study will be a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial to evaluate the safety and effectiveness of ELLANSÉ®-S for the treatment of NLFs. Subjects will be randomized to receive treatment (ELLANSÉ®-S) in one NLF and control (Radiesse®) in the contralateral NLF. A total of 126 subjects will be treated. The control and test articles will be supplied in sterile ready-to-use, pre-filled syringes. Initial treatment and any 4-week touch-up will be done consistent with initial randomization. Any retreatment(s) in either NLF will be with ELLANSÉ®-S. Subjects who meet Inclusion/Exclusion criteria will receive an initial treatment, an optional touch up at the 4-week visit, and may be eligible to receive retreatment at either 12 or 18 months after treatment (determined by when the fold has returned to baseline score, or the fold has lost at least 1 point on the Wrinkle Severity Rating Scale (WSRS) from optimal improvement). Retreatment to one side is allowed if only one side qualifies, but the other side may not be retreated at a later visit. If retreatment occurs, the subject may also be eligible to receive an optional touch up at the 4-week follow up visit. If a touch up occurs after the initial or retreatment injection, the subject will return for an additional safety visit 2 weeks after each injection. A week 4 safety visit will occur after retreatment touch-up. Primary effectiveness will be assessed at 6 months. All subjects will be followed for a minimum of 24 months after the initial treatment phase. After each injection, subjects will be contacted by telephone call/email after 72 hours and will return for a safety visit 2 weeks after treatment. At the week 4 visit, subjects will be assessed for a touch up. If a touch up is indicated as determined by the investigator, the investigator will use the same material as that used for initial treatment for the respective side. In addition, subjects will be seen at 6 weeks 3, 6, 9, 12, 18, and 24 months (from the end of the initial treatment phase). Subjects receiving a retreatment (at 12 or 18 months after treatment) will return for additional safety visits at 2 weeks and 3 and 6 months after this retreatment (the 6 month coincides with regularly scheduled visit). Subjects will have the option of a retreatment touch up injection at 4 weeks after retreatment, and if they do will have another call at 72hrs and a week 2 safety visit. The validated Wrinkle Severity Rating Scale will be used for assessment of the primary effectiveness endpoint (1). Assessment of the secondary effectiveness endpoints will include use of WSRS, the Global Aesthetic Improvement Scale (GAIS), VAS pain assessment, the validated FACE-Q Appraisal of Nasolabial Folds Questionnaire, the FACE-Q Satisfaction with Treatment Outcome Scale and the FACE-Q Age Appraisal VAS. The study will last approximately 30 months. All subjects will be recruited within approximately 6 months after the recruitment of the first subject and followed for a minimum of 24 months after the initial treatment visit. Subjects receiving a retreatment (at 12 or 18 months) will receive a telephone call/email 72 hours after retreatment and they will return for an additional safety visit 2 weeks after retreatment. Subjects may receive a retreatment touch up at 4 weeks after retreatment, and if touched up, will have safety visits at 2 and 4 weeks. All retreated subjects will also be asked to attend month 3 and month 6 safety visits. The 6-month safety visit will correspond with the next study visit (e.g., 18 month or 24-month visit depending on when they are reinjected) 126 male and female subjects will be enrolled. This enrollment number accounts for a 20% attrition rate, to ensure an adequate safety population for long-term follow-up, and a Per Protocol Set (PPS) of at least 101 NLFs per treatment arm. At least 20% of treated subjects will have Fitzpatrick Skin Types IV, V, and VI. Of these, at least, 10% will be Type IV, 5% Type V and 5% Type VI. The investigative sites will be encouraged to enroll both male and female subjects. In addition, up to 2 non-randomized, non-split-face run-in subjects will be treated with ELLANSÉ®-S by each investigator to allow the investigator to become familiar with injection characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort. Up to seven US sites will participate.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:22+

126 Participants Needed

Hyaluronic Acid Fillers for Wrinkles

Santa Rosa Beach, Florida
This is a randomized, split-face, subject-blinded, comparative study. Subjects will receive initial treatment with Defyne on one of the NLFs and with RHA3 on the other based on the pre-determined randomization. 4 weeks after the initial treatment, subjects will receive optional touch-up on one side or both sides at the Investigator's discretion for optimal correction. Subjects to return to the site at Month 3, 6, and 12 for follow-ups.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:22 - 65

15 Participants Needed

Why Other Patients Applied

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50

"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

HZ
Arthritis PatientAge: 78

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

IZ
Healthy Volunteer PatientAge: 38

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Why We Started Power

We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.

Bask
Bask GillCEO at Power
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Frequently Asked Questions

How much do Nasolabial Folds clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Nasolabial Folds clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Nasolabial Folds trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Nasolabial Folds is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Nasolabial Folds medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Nasolabial Folds clinical trials?

Most recently, we added Ellansé S for Nasolabial Folds and Hyaluronic Acid Fillers for Wrinkles to the Power online platform.

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