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OpenTrials
Completed

NCT Number: NCT01712451

Dose-ranging Study

Dose ranging study

Completed

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Key information

Conditions

Abdominal Contour Defects Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beverly Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

salmeterol xinafoate, fluticasone propionate

Drug

LIPO-102

Other names: LIPO-102

Placebo

Drug

Placebo

Salmeterol xinafoate

Drug

Salmeterol

Primary outcomes

  1. Safety

    Time frame: 8 weeks treatment

    physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events

  2. Change in abdominal circumference

    Time frame: Baseline to 9 weeks

    abdominal circumference

Secondary outcomes

  1. Change in global clinician scale score

    Time frame: Baseline to 9 weeks

  2. Change in global patient scale score

    Time frame: Baseline to 9 weeks

  3. Change in Photonumeric scale score

    Time frame: Baseline to 9 weeks

  4. Change in Patient Reported Outcome Score

    Time frame: Baseline to 9 weeks

Sponsors and collaborators

Lead sponsor

Neothetics, Inc

Industry

Registry information

Official study title

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

Acronym: LIPO-102-CL-11

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 23, 2012
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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