Dose-ranging Study

Abdominal Contour Defects Clinical Trial

— LIPO-102-CL-11  

Official title:

Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712451
• Other study ID #: LIPO-102-CL-11
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2012
• Last updated: March 5, 2015
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2015
• Source: Neothetics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Dose ranging study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Contour Defects

Intervention

Drug:
• salmeterol xinafoate, fluticasone propionate
LIPO-102
• Placebo
Placebo
• salmeterol xinafoate
Salmeterol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neothetics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events	8 weeks treatment	No
Primary	Change in abdominal circumference	abdominal circumference	Baseline to 9 weeks	No
Secondary	Change in global clinician scale score		Baseline to 9 weeks	No
Secondary	Change in global patient scale score		Baseline to 9 weeks	No
Secondary	Change in Photonumeric scale score		Baseline to 9 weeks	No
Secondary	Change in Patient Reported Outcome Score		Baseline to 9 weeks	No