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

NCT03682471 | Completed

• 3 other identifiers: 1403740160452011-005026-21
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 18

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.

Conditions

Subcutaneous Fat

Keywords

submental fat reduction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (3)

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

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

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

Interventions

Deoxycholic acid Injection DRUG

Solution for subcutaneous injection.

Also known as: Kybella

Deoxycholic Acid Injection, 10 mg/mL; Deoxycholic Acid Injection, 5 mg/mL

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Allergan: lead

Study Sites (18)

Licca Clinical Research Institute

Augsburg, 86179, Germany

Location

Campus Charité Mitte, Klinik für Dermatologie, Venerologie und Allergologie

Berlin, 10117, Germany

Location

Ruhruniversität Bochum - St. Josef Hospital

Bochum, 44791, Germany

Location

Klinikum Darmstadt

Darmstadt, 64297, Germany

Location

Krankenhaus Dresden- Friedrichstadt Klinik für Dermatologie und Allergologie

Dresden, 01067, Germany

Location

Dr. Beatrice Gerlach

Dresden, 01097, Germany

Location

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

Frankfurt, 60596, Germany

Location

Hautarztpraxis Cutanis

Freiburg im Breisgau, 79117, Germany

Location

Praxis Dr. Walker and Dr. Biwer

Ludwigshafen, 67061, Germany

Location

Universitätsklinik Schleswig Holstein, Campus Luebeck, Klinik f. Dermatologie

Lübeck, 23538, Germany

Location

Gemeinschaftsprax is für Dermatologie

Mahlow, 15831, Germany

Location

Ludwig- Maximilians- Universität München, Klinik für Dermatologie und Allergologie

München, 80337, Germany

Location

Germania Campus PraxisKlinik

Münster, 48159, Germany

Location

Praxis Dr. Graefe

Northeim, 37154, Germany

Location

Haut- und Laserzentrum Potsdam

Potsdam, 14467, Germany

Location

Klinik für Dermatologie und Allergologie Klinikum Vest GmbH Recklinghausen

Recklinghausen, 45657, Germany

Location

Hautzentrum am Starnberger See GmbH

Starnberg, 82319, Germany

Location

Dermatologische Privatpraxis

Wuppertal, 42287, Germany

Location

MeSH Terms

Interventions

Deoxycholic Acid

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Beta Bowen

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 24, 2018
• Study Start: February 14, 2012
• Primary Completion: December 13, 2013
• Study Completion: December 13, 2013
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

DE (18)