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Dose-ranging Study (LIPO-102-CL-11)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01712451
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Dose ranging study

Condition or disease Intervention/treatment Phase
Abdominal Contour Defects Drug: salmeterol xinafoate, fluticasone propionate Drug: Placebo Drug: salmeterol xinafoate Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects
Study Start Date : August 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: LIPO-102, Low Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Name: LIPO-102
Experimental: LIPO-102, Mid Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Name: LIPO-102
Experimental: LIPO-102, High Drug: salmeterol xinafoate, fluticasone propionate
LIPO-102
Other Name: LIPO-102
Experimental: LIPO-102; Placebo Drug: Placebo
Placebo
Experimental: salmeterol xinafoate Drug: salmeterol xinafoate
Salmeterol


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712451


Locations
United States, California
Beverly Hills, California, United States
San Diego, California, United States
United States, New York
New York, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Plano, Texas, United States
Sponsors and Collaborators
Neothetics, Inc
Investigators
Study Director: Murray Maytom Neothetics, Inc
More Information

Responsible Party: Neothetics, Inc
ClinicalTrials.gov Identifier: NCT01712451     History of Changes
Other Study ID Numbers: LIPO-102-CL-11
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Neothetics, Inc:
adiposity

Additional relevant MeSH terms:
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action