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

Sponsors

Lead Sponsor: Allergan

Source 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.

Overall Status Completed
Start Date 2012-02-14
Completion Date 2013-12-13
Primary Completion Date 2013-12-13
Study Type Observational
Primary Outcome
Measure 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 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 LTFU Baseline (Month 0) to Month 24
Secondary Outcome
Measure 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 LTFU Baseline (Month 0) to Month 24
Patient-Reported Submental Fat Impact Scale (PR-SMFIS) 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 LTFU Baseline (Month 0) to Month 24
Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) Up to approximately 24 months
Percentage of Participants with Treatment-emergent Adverse Events Associated with the Treatment Area (Drug-related) Up to approximately 24 months
Percentage of Participants with Treatment-emergent Adverse Events of Special Interest (AESIs) Up to approximately 24 months
Enrollment 201
Condition
Intervention

Intervention Type: Drug

Intervention Name: Deoxycholic acid Injection

Description: Solution for subcutaneous injection.

Other Name: Kybella

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: Placebo

Eligibility

Sampling Method:

Probability Sample

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Beta Bowen Study Director Allergan
Location
Facility:
Licca Clinical Research Institute | Augsburg, 86179, Germany
Campus Charité Mitte, Klinik für Dermatologie, Venerologie und Allergologie | 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, 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
Location Countries

Germany

Verification Date

2018-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Label: Deoxycholic Acid Injection, 5 mg/mL

Description: 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.

Label: Deoxycholic Acid Injection, 10 mg/mL

Description: 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.

Label: Placebo

Description: Non-treatment observational follow-up study: Participants were previously treated with placebo in studies ATX-101-10-16 or ATX-101-10-17.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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