Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)
- Registration Number
- NCT03682471
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- Signed written informed consent before any study-related activities are carried out
- Any participant who successfully completed the final visit (visit 7) of a phase 3 clinical trial, ATX-101-10-16 or ATX-101-10-17 for the reduction of submental fat, i.e. subjects must have at least one study treatment administered and have completed the predecessor study up to visit 7
- Willingness to comply with the schedule and procedures of the study
- Participants who, since the completion of the prior phase 3 study ATX-101-10-16 or ATX-101-10-17, have had or who are undergoing treatment that may affect the evaluation of the submental area (e.g. - but not limited to - long-term treatment with systemic corticosteroids, liposuction, surgery or other lipolytic treatment in the submental area, treatment with radio frequency, laser procedures, chemical peels, dermal fillers in the neck or chin area or botulinum toxin injections in the neck or chin area)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Deoxycholic Acid Injection, 5 mg/mL Deoxycholic acid Injection 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. Placebo Placebo Non-treatment observational follow-up study: Participants were previously treated with placebo in studies ATX-101-10-16 or ATX-101-10-17. Deoxycholic Acid Injection, 10 mg/mL Deoxycholic acid Injection 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.
- Primary Outcome Measures
Name Time Method 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 LTFU Baseline (Month 0) to Month 24 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.
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 LTFU Baseline (Month 0) to Month 24 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.
- Secondary Outcome Measures
Name Time Method 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 LTFU Baseline (Month 0) to Month 24 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.
Patient-Reported Submental Fat Impact Scale (PR-SMFIS) LTFU Baseline (Month 0) to Month 24 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.
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 LTFU Baseline (Month 0) to Month 24 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.
Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) Up to approximately 24 months 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.
Percentage of Participants with Treatment-emergent Adverse Events Associated with the Treatment Area (Drug-related) Up to approximately 24 months 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.
Percentage of Participants with Treatment-emergent Adverse Events of Special Interest (AESIs) Up to approximately 24 months 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.
Trial Locations
- Locations (18)
Licca Clinical Research Institute
🇩🇪Augsburg, Germany
Dr. Beatrice Gerlach
🇩🇪Dresden, Germany
Hautarztpraxis Cutanis
🇩🇪Freiburg, Germany
Klinikum der Johann-Wolfgang Goethe-Universität - Klinik für Dermatologie, Venerologie und Allergologie
🇩🇪Frankfurt, Germany
Praxis Dr. Walker and Dr. Biwer
🇩🇪Ludwigshafen, Germany
Universitätsklinik Schleswig Holstein, Campus Luebeck, Klinik f. Dermatologie
🇩🇪Lübeck, Germany
Ludwig- Maximilians- Universität München, Klinik für Dermatologie und Allergologie
🇩🇪München, Germany
Haut- und Laserzentrum Potsdam
🇩🇪Potsdam, Germany
Klinik für Dermatologie und Allergologie Klinikum Vest GmbH Recklinghausen
🇩🇪Recklinghausen, Germany
Dermatologische Privatpraxis
🇩🇪Wuppertal, Germany
Germania Campus PraxisKlinik
🇩🇪Münster, Germany
Hautzentrum am Starnberger See GmbH
🇩🇪Starnberg, Germany
Campus Charité Mitte, Klinik für Dermatologie, Venerologie und Allergologie
🇩🇪Berlin, Germany
Ruhruniversität Bochum - St. Josef Hospital
🇩🇪Bochum, Germany
Klinikum Darmstadt
🇩🇪Darmstadt, Germany
Krankenhaus Dresden- Friedrichstadt Klinik für Dermatologie und Allergologie
🇩🇪Dresden, Germany
Gemeinschaftsprax is für Dermatologie
🇩🇪Mahlow, Germany
Praxis Dr. Graefe
🇩🇪Northeim, Germany