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RZL-012 50mg/ml for Flank Mass

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 12 weeks for the double-blind phase and 12 weeks for the open-label phase. baseline for the open-label phase considered to be 12 weeks after double blind treatment
Awards & highlights

Study Summary

This trial will test the safety and efficacy of RZL-012, a new potential treatment for acne. A total of 24 subjects will be given the treatment or a placebo, and monitored for 12 weeks. After that, the trial will be repeated with the other group of subjects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks for the double-blind phase and 12 weeks for the open-label phase. baseline for the open-label phase considered to be 12 weeks after double blind treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for the double-blind phase and 12 weeks for the open-label phase. baseline for the open-label phase considered to be 12 weeks after double blind treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-related Adverse Events [AEs]
Secondary outcome measures
Efficacy - Change in Satisfaction Score
Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale
Efficacy - Relative Change in Measured Fat Volume
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: RZL-012 50mg/mlActive Control1 Intervention
Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.
Group II: PlaceboPlacebo Group1 Intervention
Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.

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Who is running the clinical trial?

Raziel Therapeutics Ltd.Lead Sponsor
9 Previous Clinical Trials
356 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
2022. "Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445557.
~4 spots leftby Apr 2025
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