At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓BMI >22 and <40 kg/m²
- ✓Grade 3–4 submental fat (SMF) by C-CAT and S-CAT rating
- ✓Submental fat bulge fits 32±4 injection sites on 1 cm grid
- ✕Unable to tolerate subcutaneous injections
- ✕Dysfunctional gallbladder (cholecystectomy, cholecystitis)
- ✕Systemic diseases including gastritis/ulcers, renal dysfunction, hypertension, liver disease, glaucoma, diabetes, cardiovascular disease
- ✕Contraindications to oral corticosteroids, NSAIDs, or antihistamines
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Phase 2 Study to Evaluate the Effects of a Local Anesthetic, Anti-inflammatory Medications and Compression Garments on RZL-012-Induced Adverse Events
In Brief
A Phase 2 clinical trial evaluating RZL-012, RZL-012+Lidacaine injection prior treatment, and 3 other interventions for Submental Fat. Completed, enrolled 48 participants across 1 site.
Detailed Summary
This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:
Study Details
Timeline
Interventions
50mg/ml drug formulation
5ml lidocaine will be injected 10 minutes before RZL-012 treatment
oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
Universal Facial Band