Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat

• Status: Completed
• Trial end date: 2017-06-02
• Target enrollment: 0
• Participant gender: All

Summary

Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on submental bulging due to subcutaneous fat. Approximately 150 participants of either gender who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS]) will be recruited for this study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neothetics, Inc
• Treatments: Salmeterol Xinafoate

Criteria

Inclusion Criteria:

1. Healthy males or non-pregnant females;

2. Capable of providing written, informed consent; and ,

3. Have submental bulging that is evaluated by the Investigator as "Moderate" or "Large".

Exclusion Criteria:

1. History of prior treatment to reduce submental bulging;

2. History of derm fillers, chemical peels, or laser or radio frequency procedures in the neck/chin area within 12 months of screening;

3. History of botulinum toxin in the neck/chin area within 6 months of screening;

4. Any skin conditions (including, but not limited to: skin infections, psoriasis, eczema, keloids, tattoos or hypertrophic or tethered scars) or history of trauma in the treatment area that may affect study procedures;

5. A score of 4 (Extreme Laxity) on the Skin Laxity Assessment Scale at Visit 1 (Screening);

6. Any known hypersensitivity to the study drug and/or any of the components;

7. Prior or current enrollment in any Lithera/Neothetics sponsored LIPO-102/LIPO-202 study;

8. Concurrently enrolled in another investigational drug or device study or used any experimental or investigational drug or device within 30 days of screening;

9. Female subject who is pregnant or lactating;

10. Any medical condition that in the opinion of the Investigator might complicate study procedures or assessments or jeopardize the subject's safety, including, but not limited to:

1. any bleeding or connective tissue disorders;

2. any clinically significant kidney or liver disease;

3. any untreated thyroid disease;

4. asthma, COPD, diabetes (Type I and II) or cardiovascular disease

5. history of major surgery within 30 days prior to randomization, or planned surgery during the study period;

11. Used drugs with anticoagulant activity (including aspirin) within 14 days prior to randomization, β adrenergic receptor agonists or blockers, strong CYP3A inhibitors, or nonpotassium sparing diuretics (e.g., loop or thiazide diuretics) within 28 days prior to randomization;

12. Used tricyclic antidepressants or monoamine oxidase inhibitor medications within 14 days prior to randomization;

13. Unlikely or unable to adhere to the study visit schedule or comply with protocol procedures.