Dose-ranging Study

Phase 2

Completed

• Conditions: Abdominal Contour Defects
• Interventions: Drug: salmeterol xinafoate, fluticasone propionate; Drug: Placebo; Drug: salmeterol xinafoate

• Registration Number: NCT01712451
• Lead Sponsor: Neothetics, Inc

Brief Summary

Dose ranging study

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-23
• 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: 200

Inclusion Criteria

• 18 - 45 years of age inclusive
• abdominal contour defect
• BMI <25 kg/msq
• Stable diet and exercise and body weight

Exclusion Criteria

• Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)
• Known hypersensitivity to study drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIPO-102, High	salmeterol xinafoate, fluticasone propionate	-
LIPO-102, Low	salmeterol xinafoate, fluticasone propionate	-
LIPO-102; Placebo	Placebo	-
LIPO-102, Mid	salmeterol xinafoate, fluticasone propionate	-
salmeterol xinafoate	salmeterol xinafoate	-

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 abdominal circumference	Baseline to 9 weeks	abdominal circumference

Secondary Outcome Measures

Name	Time	Method
Change in Patient Reported Outcome Score	Baseline to 9 weeks
Change in global clinician scale score	Baseline to 9 weeks
Change in global patient scale score	Baseline to 9 weeks
Change in Photonumeric scale score	Baseline to 9 weeks