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

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ClinicalTrials.gov Identifier: NCT03682471
Recruitment Status : Completed
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment
Subcutaneous Fat Drug: Deoxycholic acid Injection Drug: Placebo

Study Design
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Study Type : Observational
Actual Enrollment : 201 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : February 14, 2012
Actual Primary Completion Date : December 13, 2013
Actual Study Completion Date : December 13, 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: 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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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.

  2. 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 [ Time Frame: 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 :
  1. 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 [ Time Frame: 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.

  2. Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [ Time Frame: 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.

  3. 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 [ Time Frame: 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.

  4. Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: 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.

  5. Percentage of Participants with Treatment-emergent Adverse Events Associated with the Treatment Area (Drug-related) [ Time Frame: 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.

  6. Percentage of Participants with Treatment-emergent Adverse Events of Special Interest (AESIs) [ Time Frame: 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.


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03682471


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Beta Bowen Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03682471    
Obsolete Identifiers: NCT02052622
Other Study ID Numbers: 1403740
16045 ( Other Identifier: Company internal )
2011-005026-21 ( EudraCT Number )
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Keywords provided by Allergan:
submental fat reduction
Additional relevant MeSH terms:
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Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents