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

Long-term, Follow-up Study of Subjects Who Completed Phase III Trials ATX-101-10-16 or ATX-101-10-17 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

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 Overview

• Status: Completed
• Conditions: Subcutaneous Fat
• Intervention / Treatment: Drug: Deoxycholic acid Injection; Drug: Placebo

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany, 86179
    • Licca Clinical Research Institute
  • Berlin, Germany, 10117
    • Campus Charité Mitte, Klinik für Dermatologie, Venerologie und Allergologie
  • Bochum, Germany, 44791
    • Ruhruniversität Bochum - St. Josef Hospital
  • Darmstadt, Germany, 64297
    • Klinikum Darmstadt
  • Dresden, Germany, 01067
    • Krankenhaus Dresden- Friedrichstadt Klinik für Dermatologie und Allergologie
  • Dresden, Germany, 01097
    • Dr. Beatrice Gerlach
  • Frankfurt, Germany, 60596
    • Klinikum der Johann-Wolfgang Goethe-Universität - Klinik für Dermatologie, Venerologie und Allergologie
  • Freiburg, Germany, 79117
    • Hautarztpraxis Cutanis
  • Ludwigshafen, Germany, 67061
    • Praxis Dr. Walker and Dr. Biwer
  • Lübeck, Germany, 23538
    • Universitätsklinik Schleswig Holstein, Campus Luebeck, Klinik f. Dermatologie
  • Mahlow, Germany, 15831
    • Gemeinschaftsprax is für Dermatologie
  • München, Germany, 80337
    • Ludwig- Maximilians- Universität München, Klinik für Dermatologie und Allergologie
  • Münster, Germany, 48159
    • Germania Campus PraxisKlinik
  • Northeim, Germany, 37154
    • Praxis Dr. Graefe
  • Potsdam, Germany, 14467
    • Haut- und Laserzentrum Potsdam
  • Recklinghausen, Germany, 45657
    • Klinik für Dermatologie und Allergologie Klinikum Vest GmbH Recklinghausen
  • Starnberg, Germany, 82319
    • Hautzentrum am Starnberger See GmbH
  • Wuppertal, Germany, 42287
    • Dermatologische Privatpraxis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Deoxycholic acid Injection; Solution for subcutaneous injection.; Other Names: Kybella
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.	Drug: Deoxycholic acid Injection; Solution for subcutaneous injection.; Other Names: Kybella
Placebo; Non-treatment observational follow-up study: Participants were previously treated with placebo in studies ATX-101-10-16 or ATX-101-10-17.	Drug: Placebo; Placebo, 10 mM sodium phosphate, 0.9% [w/v] sodium chloride in water for subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Beta Bowen, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2012
• Primary Completion (Actual): December 13, 2013
• Study Completion (Actual): December 13, 2013

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: submental fat reduction
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: 1403740; 16045 (Company internal); 2011-005026-21 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No