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

Neothetics

Status and phase: Completed; Phase 2

Conditions: Abdominal Contour Defects

Treatments: Drug: Placebo; Drug: salmeterol xinafoate, fluticasone propionate; Drug: salmeterol xinafoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01712451

LIPO-102-CL-11

Details and patient eligibility

About

Dose ranging study

Enrollment: 200 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 5 patient groups

LIPO-102, Low

Experimental group

Treatment:

Drug: salmeterol xinafoate, fluticasone propionate

LIPO-102, Mid

Experimental group

Treatment:

Drug: salmeterol xinafoate, fluticasone propionate

LIPO-102, High

Experimental group

Treatment:

Drug: salmeterol xinafoate, fluticasone propionate

LIPO-102; Placebo

Experimental group

Treatment:

Drug: Placebo

salmeterol xinafoate

Experimental group

Treatment:

Drug: salmeterol xinafoate