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| ID | Type | Description | Link |
|---|---|---|---|
| 16045 | Other Identifier | Company internal | |
| 2011-005026-21 | EudraCT Number |
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The objective of this non-treatment, placebo-controlled, observational, 24-month follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study. Participants who previously received deoxycholic acid injections in studies ATX-101-10-16 [NCT01305577] or ATX-101-10-17 [NCT01294644] were enrolled in this non-treatment observational follow-up study to further evaluate safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deoxycholic Acid Injection, 5 mg/mL | Non-treatment observational follow-up study: Participants were previously treated with deoxycholic acid injection, 5 mg/mL in studies ATX-101-10-16 or ATX-101-10-17. |
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| Deoxycholic Acid Injection, 10 mg/mL | Non-treatment observational follow-up study: Participants were previously treated with deoxycholic acid injection, 10 mg/mL in studies ATX-101-10-16 or ATX-101-10-17. |
| |
| Placebo | Non-treatment observational follow-up study: Participants were previously treated with placebo in studies ATX-101-10-16 or ATX-101-10-17. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic acid Injection | Drug | Solution for subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-Grade Response During the 24 Months of Follow up, i.e. % of Participants who were CR-SMFRS 1-Grade Responders at both LTFU Baseline and at 24-Month Visit | The CR-SMFRS was based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. 1-grade response=At least a 1-grade reduction from original study baseline in the CR-SMFRS assessment. | LTFU Baseline (Month 0) to Month 24 |
| Percentage of Participants with Maintenance of Response as Assessed by the Subject Satisfaction Rating Scale (SSRS) During the 24 Months of Follow up, i.e. % of Participants who were SSRS Responders at both LTFU Baseline and at 24-Month Visit | For the SSRS, the participant was asked to answer the question: "Considering your appearance in association with your face and chin, how satisfied do you feel with your appearance at the present time?" using a 7-point scale: 0=Extremely dissatisfied, 1=Dissatisfied, 2=Slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=Slightly satisfied, 5=Satisfied, and 6=Extremely satisfied. SSRS responder was a participant whose response was ≥ 4. | LTFU Baseline (Month 0) to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 2-Grade Response During the 24 Months of Follow up, i.e. % of Participants who were CR-SMFRS 2-Grade Responders at both LTFU Baseline and at 24-Month Visit | The CR-SMFRS was based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. 2- grade response=At least a 2-grade reduction from original study baseline in the CR-SMFRS assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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A subset of participants at selected centers who had successfully completed Phase 3 clinical studies ATX-101-10-16 or ATX-101-10-17 for the reduction of submental fat were enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Beta Bowen | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Licca Clinical Research Institute | Augsburg | 86179 | Germany | |||
| Campus Charité Mitte, Klinik für Dermatologie, Venerologie und Allergologie |
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| Placebo | Drug | Placebo, 10 mM sodium phosphate, 0.9% [w/v] sodium chloride in water for subcutaneous injection. |
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| LTFU Baseline (Month 0) to Month 24 |
| Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | The PR-SMFIS assessed the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item was rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where low scores reflect a positive impact and high scores reflect a negative impact. | LTFU Baseline (Month 0) to Month 24 |
| Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During the 24 Months of Follow up, i.e. % of Participants who were Composite SMFRS 1-Grade Responders at both LTFU Baseline and at 24-Month Visit | Participants who had at least a 1-grade reduction in both the CR-SMFRS and PR-SMFRS from the original baseline value in the predecessor study were defined as composite SMFRS-1 responders. | LTFU Baseline (Month 0) to Month 24 |
| Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event was any undesirable medical occurrence or worsening of an existing condition, irrespective of whether the event was considered treatment-related. A treatment-emergent adverse event was defined as an adverse event with an onset that occurs after receiving treatment. | Up to approximately 24 months |
| Percentage of Participants with Treatment-emergent Adverse Events Associated with the Treatment Area (Drug-related) | An adverse event was any undesirable medical occurrence or worsening of an existing condition, irrespective of whether the event was considered treatment-related. A treatment-emergent adverse event was defined as an adverse event with an onset that occurs after receiving treatment. | Up to approximately 24 months |
| Percentage of Participants with Treatment-emergent Adverse Events of Special Interest (AESIs) | An adverse event was any undesirable medical occurrence or worsening of an existing condition, irrespective of whether the event was considered treatment-related. A treatment-emergent adverse event was defined as an adverse event with an onset that occurs after receiving treatment. AESIs for this study are common treatment reactions (consistently reported for overall AEs, treatment area-related AEs, or study-drug-related AEs) that were observed in earlier deoxycholic acid injection studies and identified as likely to be related to the injection procedure. | Up to approximately 24 months |
| Berlin |
| 10117 |
| Germany |
| Ruhruniversität Bochum - St. Josef Hospital | Bochum | 44791 | Germany |
| Klinikum Darmstadt | Darmstadt | 64297 | Germany |
| Krankenhaus Dresden- Friedrichstadt Klinik für Dermatologie und Allergologie | Dresden | 01067 | Germany |
| Dr. Beatrice Gerlach | Dresden | 01097 | Germany |
| Klinikum der Johann-Wolfgang Goethe-Universität - Klinik für Dermatologie, Venerologie und Allergologie | Frankfurt | 60596 | Germany |
| Hautarztpraxis Cutanis | Freiburg im Breisgau | 79117 | Germany |
| Praxis Dr. Walker and Dr. Biwer | Ludwigshafen | 67061 | Germany |
| Universitätsklinik Schleswig Holstein, Campus Luebeck, Klinik f. Dermatologie | Lübeck | 23538 | Germany |
| Gemeinschaftsprax is für Dermatologie | Mahlow | 15831 | Germany |
| Ludwig- Maximilians- Universität München, Klinik für Dermatologie und Allergologie | München | 80337 | Germany |
| Germania Campus PraxisKlinik | Münster | 48159 | Germany |
| Praxis Dr. Graefe | Northeim | 37154 | Germany |
| Haut- und Laserzentrum Potsdam | Potsdam | 14467 | Germany |
| Klinik für Dermatologie und Allergologie Klinikum Vest GmbH Recklinghausen | Recklinghausen | 45657 | Germany |
| Hautzentrum am Starnberger See GmbH | Starnberg | 82319 | Germany |
| Dermatologische Privatpraxis | Wuppertal | 42287 | Germany |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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