Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)

Allergan201 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

201

Conditions

Subcutaneous Fat

Interventions

Deoxycholic acid InjectionDRUG

Solution for subcutaneous injection.

PlaceboDRUG

Placebo, 10 mM sodium phosphate, 0.9% \[w/v\] sodium chloride in water for subcutaneous injection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Locations (18)

Licca Clinical Research Institute

Augsburg, Germany

Campus Charité Mitte, Klinik für Dermatologie, Venerologie und Allergologie

Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: LTFU Baseline (Month 0) to Month 24

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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Ruhruniversität Bochum - St. Josef Hospital

Bochum, Germany

Klinikum Darmstadt

Darmstadt, Germany

Krankenhaus Dresden- Friedrichstadt Klinik für Dermatologie und Allergologie

Dresden, Germany

Dr. Beatrice Gerlach

Dresden, Germany

Klinikum der Johann-Wolfgang Goethe-Universität - Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt, Germany

Hautarztpraxis Cutanis

Freiburg im Breisgau, Germany

Praxis Dr. Walker and Dr. Biwer

Ludwigshafen, Germany

Universitätsklinik Schleswig Holstein, Campus Luebeck, Klinik f. Dermatologie

Lübeck, Germany

...and 8 more locations

Time frame: 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.

Time frame: 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.

Time frame: LTFU Baseline (Month 0) to Month 24

Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE)

Time frame: Up to approximately 24 months

Percentage of Participants with Treatment-emergent Adverse Events Associated with the Treatment Area (Drug-related)

Time frame: 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.

Time frame: Up to approximately 24 months