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RZL-012 50mg/ml for Double Chin
Study Summary
This trial will offer a second treatment session of RZL-012 to those who completed a previous trial and showed improvement in their double chin. The safety and efficacy of the injection will be monitored for 84 days.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 28 Patients • NCT04086823Trial Design
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- You have certain facial features or conditions that might make it difficult to accurately assess the study treatment's effects on your face.You have been taking over-the-counter pain relievers like ibuprofen or aspirin for at least a week before joining the study.You have a specific type of bulge that can receive a series of injections spaced 1 cm apart in a grid pattern.You cannot handle or tolerate injections under the skin.You have a large amount of fat under your chin that cannot be treated with a series of injections.You don't have enough fat under your chin for the required number of injections.You have experienced allergic reactions to medications that are given by injection.You have received injections of botulinum toxin in your neck or chin area within the past nine months.You have experienced serious side effects or allergic reactions from previous treatments in the RZL-012 studies.You have a medical condition, like a swollen thyroid or enlarged lymph nodes, that may cause increased fullness under the chin.You are currently taking medication for a blood clotting disorder or have a history of such disorder.You or someone in your family has had blood clots in the veins before.Your body mass index (BMI) is between 22 and 40, which means you are not underweight or extremely overweight.You have a skin condition on your chin area that may make it difficult for the researcher to accurately evaluate or analyze the study results.You have a pre-existing condition affecting your ability to swallow, speak, or control facial muscles.You have Dercum's Disease.
- Group 1: RZL-012 50mg/ml
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do applicants for this trial need to be younger than fifty-five years of age?
"As established by the criteria for admission, individuals must be 18 years old or older to participate and no more than 65."
What potential harms might patients incur if they take RZL-012 50mg/ml?
"Our team at Power has given RZL-012 50mg/ml a safety rating of 2 due to the relatively limited data found during Phase 2 trials, which suggests some degree of safety but no efficacy."
Would I be eligible to partake in this experiment?
"Eligibility criteria for this trial includes double chin and age ranging between 18-65. The entire research is aiming to enrol 30 participants."
How many individuals have enrolled for this research endeavor?
"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this medical experiment, posted May 29th 2023, is currently looking for participants. A total of 30 patients need to be enrolled from one institution."
Is access to this research protocol available at the moment?
"Affirmative. Clinical trials.gov serves as confirmation that this clinical trial is actively accepting applicants, having been first posted on May 29th 2023 and updated most recently June 26th 2023. 30 patients are needed to enrol at a single site."
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