Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
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| ClinicalTrials.gov Identifier: NCT02398188 |
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Recruitment Status :
Completed
First Posted : March 25, 2015
Results First Posted : January 7, 2019
Last Update Posted : January 7, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Central Abdominal Bulging | Drug: LIPO-202 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 793 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat in Non-Obese Subjects |
| Actual Study Start Date : | April 9, 2015 |
| Actual Primary Completion Date : | October 29, 2015 |
| Actual Study Completion Date : | October 29, 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: LIPO-202
Experimental arm
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Drug: LIPO-202
Other Name: Salmeterol |
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Placebo Comparator: Placebo
Placebo comparator
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Drug: Placebo
Other Name: Placebo for LIPO-202 |
- Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response [ Time Frame: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment) ]
The composite P-GAPS1/CPnS2 response was defined as at least a 1 point (grade) improvement in P-GAPS and at least a 2 point (grade) improvement in CPnS from baseline after 8 weeks of treatment.
Patient - Global Abdominal Perception Scale (P-GAPS) - a patient views and assesses the contour of their abdomen on a 5-point verbal scale ranging from "Flat" to "Big Bulge".
Clinician Photonumeric Scale (CPnS) - a trained clinician rater examines the subject's abdomen and matches the subject's abdominal bulge/profile to the nearest gender-specific abdominal photo on the 6-point scale.
- Percent Change in the Patient Reported Global Abdominal Perception Score [ Time Frame: 8 weeks post the start of treatment ]1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.
- Percent Change in Waist Circumference [ Time Frame: 8 weeks post the start of treatment ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male or non-pregnant female subjects
- Capable of providing written consent.
- BMI < 30 kg/m2
- Stable diet and exercise routine
- Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat
Exclusion Criteria:
- Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
- Plan on starting a weight loss or exercise program during the study.
- Known hypersensitivity to study drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398188
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| Study Director: | Maria Feldman | Neothetics, Inc |
| Responsible Party: | Evofem Inc. |
| ClinicalTrials.gov Identifier: | NCT02398188 |
| Other Study ID Numbers: |
LIPO-202-CL-19 |
| First Posted: | March 25, 2015 Key Record Dates |
| Results First Posted: | January 7, 2019 |
| Last Update Posted: | January 7, 2019 |
| Last Verified: | October 2018 |
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