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A Study to Evaluate Safety, Tolerability of Subcutaneous Injection in Adult Subjects Undergoing Abdominoplasty
Phase 1
Waitlist Available
Led By Mark Nestor, MD
Research Sponsored by Sirnaomics
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 24 weeks
Summary
This trial involves participants receiving injections with different amounts and sizes of a new treatment. The goal is to determine the best dose and volume for the new treatment. The specific patient group is not detailed, but they are eligible for the study.
Eligible Conditions
- Abdominal Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence (severity and causality) of any AEs
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising.
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): pain and stinging/burning.
Trial Design
7Treatment groups
Experimental Treatment
Placebo Group
Group I: STP705, 320ug/mL, 1.0 ccExperimental Treatment1 Intervention
Volume of Injection 1.0cc
Group II: STP705, 320ug/mL, 0.5 ccExperimental Treatment1 Intervention
Volume of Injection 0.5cc
Group III: STP705, 240ug/mL, 1.0 ccExperimental Treatment1 Intervention
Volume of Injection 1.0cc
Group IV: STP705, 240 ug/mL, 0.5 ccExperimental Treatment1 Intervention
Volume of Injection 0.5cc
Group V: STP705, 120ug/mL, 1.0 ccExperimental Treatment1 Intervention
Volume of Injection 1.0cc
Group VI: STP705, 120ug/mL, 0.5 ccExperimental Treatment1 Intervention
Volume of Injection 0.5cc
Group VII: VehiclePlacebo Group1 Intervention
1.0cc placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
STP705
2022
Completed Phase 2
~180
Find a Location
Who is running the clinical trial?
SirnaomicsLead Sponsor
11 Previous Clinical Trials
329 Total Patients Enrolled
Mark Nestor, MDPrincipal InvestigatorCenter for Clinical and Cosmetic Research
3 Previous Clinical Trials
82 Total Patients Enrolled