Dose Ranging Study

Phase 2

Completed

• Conditions: Periumbilical Subcutaneous Adipose Tissue Reduction

• Registration Number: NCT01802723
• Lead Sponsor: Neothetics, Inc

Brief Summary

Dose Ranging Study

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Primary Completion: 2013-06
• Study Completion: 2013-10
• Status Verified: 2015-03
• Disposition First Submitted: 2015-03-05
• Disposition First Submitted QC: 2015-03-05
• Last Update Submitted: 2015-03-05
• Disposition First Posted: 2015-03-26
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

>18 years of age inclusive Subcutaneous fat in the periumbilical area BMI <30 kg/msq Stable diet and exercise and body weight

Exclusion Criteria

Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety	8 weeks treatment	physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
Change in global clinician abdominal perception scale score (baseline and 9 weeks)	9 weeks
Change in global patient abdominal perception scale score (baseline and 9 weeks)	9 weeks
Change in abdominal circumference (baseline and 9 weeks)	9 weeks	abdominal circumference

Secondary Outcome Measures

Name	Time	Method
Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)	9 weeks
Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)	9 weeks

Trial Locations

Locations (7)

United States, California; 🇺🇸 Santa Ana, California, United States

United States, North Carolina; 🇺🇸 Raleigh, North Carolina, United States

United States, Illinois; 🇺🇸 Chicago, Illinois, United States

United States, Florida; 🇺🇸 Tampa, Florida, United States

United States, Tennessee; 🇺🇸 Nashville, Tennessee, United States

United States, New York; 🇺🇸 Smithtown, New York, United States

United States, Texas; 🇺🇸 Plano, Texas, United States