Central Abdominal Bulging
Conditions
Brief summary
LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 (NCT02397499) or LIPO-202-CL-19 (NCT02398188). No risks related to treatment are anticipated as subjects will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on study.
Interventions
DRUGLIPO-202
DRUGPlacebo
Sponsors
Neothetics, Inc
Evofem Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy male or non-pregnant female subjects who completed Study LIPO-202-CL-18 or LIPO-202-CL-19 * Capable of providing written consent * Willing to comply with the study procedures and schedule
Exclusion criteria
* Female subjects who are pregnant or are not using adequate birth control methods * Plan on starting a weight loss or exercise program during the study * Plan to enroll in another investigational drug or device study * Unlikely or unable to adhere to the study visit schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Post-treatment Duration of Clinical Effect of LIPO-202. Photonumeric Score and Global Abdominal Perception Score. | 1 Year | Measured by change in clinician reported photonumeric score and change in patient reported global abdominal perception score. Patient-rated changes in amount of bulging or flatness of their belly using the 5-point scale provided as pictures where zero is flat and five is big bulge. |
| Evaluation of a 12-month Post-treatment, Non-interventional, Observational Period to Evaluate the Safety and Duration of Clinical Effects of LIPO-202. | 1 Year | Subjects who report an improvement of a least 1-point (grade) on the patient global abdominal perception scale and the photonumeric scale. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: LIPO-202 Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.
LIPO-202 | 50 |
| Placebo Comparator: Placebo Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.
Placebo | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 50 | 50 |
Baseline characteristics
| Characteristic | Experimental: LIPO-202 | Placebo Comparator: Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Evaluation of a 12-month Post-treatment, Non-interventional, Observational Period to Evaluate the Safety and Duration of Clinical Effects of LIPO-202.
Subjects who report an improvement of a least 1-point (grade) on the patient global abdominal perception scale and the photonumeric scale.
Time frame: 1 Year
Population: Lack of efficacy - not completed. Study was conducted by Neothetics Inc. and during a company merger with Evofem, no study data was provided. All efforts to locate this data have been exhausted, there is no longer access to this data to be reported.
Primary
Evaluation of the Post-treatment Duration of Clinical Effect of LIPO-202. Photonumeric Score and Global Abdominal Perception Score.
Measured by change in clinician reported photonumeric score and change in patient reported global abdominal perception score. Patient-rated changes in amount of bulging or flatness of their belly using the 5-point scale provided as pictures where zero is flat and five is big bulge.
Time frame: 1 Year
Population: Lack of efficacy - not completed. Study was conducted by Neothetics Inc. and during a company merger with Evofem, no study data was provided. All efforts to locate this data have been exhausted, there is no longer access to this data to be reported.