Dose-ranging Study
Overview
Dose ranging study
Full Title of Study: “Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: October 2012
Interventions
- Drug: salmeterol xinafoate, fluticasone propionate
- LIPO-102
- Drug: Placebo
- Placebo
- Drug: salmeterol xinafoate
- Salmeterol
Arms, Groups and Cohorts
- Experimental: LIPO-102, Low
- Experimental: LIPO-102, Mid
- Experimental: LIPO-102, High
- Experimental: LIPO-102; Placebo
- Experimental: salmeterol xinafoate
Clinical Trial Outcome Measures
Primary Measures
- Safety
- Time Frame: 8 weeks treatment
- physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
- Change in abdominal circumference
- Time Frame: Baseline to 9 weeks
- abdominal circumference
Secondary Measures
- Change in global clinician scale score
- Time Frame: Baseline to 9 weeks
- Change in global patient scale score
- Time Frame: Baseline to 9 weeks
- Change in Photonumeric scale score
- Time Frame: Baseline to 9 weeks
- Change in Patient Reported Outcome Score
- Time Frame: Baseline to 9 weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Neothetics, Inc
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Murray Maytom, Study Director, Neothetics, Inc
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