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RZL-012 50mg/ml for Double Chin
Phase 2
Waitlist Available
Research Sponsored by Raziel Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 84 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety - Adverse events follow up
Secondary outcome measures
Efficacy -Change in score according to Clinician chin assessment tool (C-CAT)
Side effects data
From 2020 Phase 2 trial • 28 Patients • NCT0408682363%
Injection site bruising
50%
Edema
50%
Induration
50%
Injection site pain
50%
Injection site erythema
25%
Bruising sensation
13%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
RZL-012 Cohort 1
Vehicle Cohort 2
Vehicle Cohort 1
RZL-012 Cohort 2
Trial Design
1Treatment groups
Experimental Treatment
Group I: RZL-012 50mg/mlExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RZL-012
2022
Completed Phase 2
~370
Find a Location
Who is running the clinical trial?
Raziel Therapeutics Ltd.Lead Sponsor
9 Previous Clinical Trials
353 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: RZL-012 50mg/ml
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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