Clinical trial NCT03682471: Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subcutaneous Fat
Keywords: submental fat reduction
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-09-24
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: LTFU Baseline (Month 0) to Month 24
measure: 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
timeFrame: LTFU Baseline (Month 0) to Month 24
Secondary outcomes:
measure: 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
timeFrame: LTFU Baseline (Month 0) to Month 24
measure: Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
timeFrame: LTFU Baseline (Month 0) to Month 24
measure: 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
timeFrame: LTFU Baseline (Month 0) to Month 24
measure: Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 24 months
measure: Percentage of Participants with Treatment-emergent Adverse Events Associated with the Treatment Area (Drug-related)
timeFrame: Up to approximately 24 months
measure: Percentage of Participants with Treatment-emergent Adverse Events of Special Interest (AESIs)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Licca Clinical Research Institute
city: Berlin
country: Germany
facility: Campus Charité Mitte, Klinik für Dermatologie, Venerologie und Allergologie
city: Bochum
country: Germany
facility: Ruhruniversität Bochum - St. Josef Hospital
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Dresden
country: Germany
facility: Krankenhaus Dresden- Friedrichstadt Klinik für Dermatologie und Allergologie
city: Dresden
country: Germany
facility: Dr. Beatrice Gerlach
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Wolfgang Goethe-Universität - Klinik für Dermatologie, Venerologie und Allergologie
city: Freiburg
country: Germany
facility: Hautarztpraxis Cutanis
city: Ludwigshafen
country: Germany
facility: Praxis Dr. Walker and Dr. Biwer
city: Lübeck
country: Germany
facility: Universitätsklinik Schleswig Holstein, Campus Luebeck, Klinik f. Dermatologie
city: Mahlow
country: Germany
facility: Gemeinschaftsprax is für Dermatologie
city: München
country: Germany
facility: Ludwig- Maximilians- Universität München, Klinik für Dermatologie und Allergologie
city: Münster
country: Germany
facility: Germania Campus PraxisKlinik
city: Northeim
country: Germany
facility: Praxis Dr. Graefe
city: Potsdam
country: Germany
facility: Haut- und Laserzentrum Potsdam
city: Recklinghausen
country: Germany
facility: Klinik für Dermatologie und Allergologie Klinikum Vest GmbH Recklinghausen
city: Starnberg
country: Germany
facility: Hautzentrum am Starnberger See GmbH
city: Wuppertal
country: Germany
facility: Dermatologische Privatpraxis
Study officials:
affiliation: Allergan
name: Beta Bowen
role: STUDY_DIRECTOR
References: