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

Submental Fat Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of LIPO-202 (Salmeterol Xinafoate for Injection) for the Reduction of Submental Subcutaneous Fat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005717
• Other study ID #: LIPO-202-CL-31
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2016
• Last updated: October 18, 2017
• Start date: December 22, 2016
• Est. completion date: June 2, 2017

Study information

• Verified date: October 2017
• Source: Neothetics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Potential subjects will present and complete the Screening Visit. All qualifying subjects will be randomized to one of three treatment groups and treated with up to 30 subcutaneous injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon completion of treatment visits, subject will return to the clinic for a follow-up visit and end of study visit, one and four weeks after the last treatment. The number and pattern of injections will be based on the area (cm x cm) of submental fat at baseline. At each visit the subjects will also undergo an examination of the treatment area, collection of vital signs and questioning about possible adverse events (AEs).

The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit and an End of Study Visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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, ß 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.

Related Conditions & MeSH terms

• Submental Fat

Intervention

Drug:
• LIPO-202

• Placebo for LIPO-202
Lyophile manufactured to mimic LIPO-202 lyophile.

Locations

Country	Name	City	State
United States	Westlake Dermatology Clinical Research Center	Austin	Texas
United States	Clinical Testing of Beverly Hills	Beverly Hills	California
United States	Skin Research Institute	Coral Gables	Florida
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	AboutSkin Research	Greenwood Village	Colorado
United States	Ablon Skin Institute And Research Center	Manhattan Beach	California
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Juva Skin & Laser Center	New York	New York
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Grekin Skin Institute	Warren	Michigan
United States	Mercy Research	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Neothetics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by number of subjects with adverse events.		12 weeks (Baseline through 4 weeks post last dose)
Primary	Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results.		12 weeks (Baseline through 4 weeks post last dose)
Primary	Change from baseline in the patient reported submental bulging scale.	The self-rating scale is 5-point scale that the subject evaluates their submental fat.	12 weeks (Baseline through 4 weeks post last dose)
Primary	Change from baseline in the clinician reported submental bulging scale	The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.	12 weeks (Baseline through 4 weeks post last dose)
Primary	Change in submental fat thickness measured with calipers (mm).		12 weeks (Baseline through 4 weeks post last dose)