Dose-ranging Study

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01712451

Acronym

LIPO-102-CL-11

Enrollment

200

Registered

2012-10-23

Start date

2011-08-31

Completion date

2012-10-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Contour Defects

Keywords

adiposity

Brief summary

Dose ranging study

Interventions

DRUGsalmeterol xinafoate, fluticasone propionate

LIPO-102

DRUGPlacebo

Placebo

DRUGsalmeterol xinafoate

Salmeterol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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
Change in Patient Reported Outcome Score	Baseline to 9 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026