Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

Subcutaneous Fat Clinical Trial

Official title:

Long-term, Follow-up Study of Subjects Who Completed Phase 3 Trials ATX-101-10-16 or ATX-101-10-17 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052622
• Other study ID #: 1403740
• Secondary ID: 14037402011-0050
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2018
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat

Description:

In the study, patients who completed the randomized, double-blind, placebo-controlled phase 3 studies ATX-101-10-16 and ATX-101-10-17 and where recruited at German study sites are followed-up for up to 2 years. No study medication is administered in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed written informed consent before any study-related activities are carried out

• Any subject 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:

• Subjects 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)

Related Conditions & MeSH terms

• Subcutaneous Fat

Intervention

Procedure:
• Examinations and surveys
Clinical evaluation, measurement of fat deposit beneath the chin by skinfold caliper, patient-reported outcome questionnaires, photographs, recording of adverse events

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Clinician-reported submental fat rating scale (1-grade response)	Maintenance of the treatment effect	24 months
Primary	Score on Subject satisfaction rating scale	Maintenance of the treatment effect	24 months
Secondary	Score on Clinician-reported submental fat rating scale (2-grade response)		24 months
Secondary	Score on Patient-reported submental fat impact scale (1-grade response)		24 months
Secondary	Score on Composite submental fat rating scale (1-grade response)	Improvement observed both in clinician-reported submental fat rating scale and patient-reported submental fat rating scale	24 months
Secondary	Number and percentage of subjects with treatment-emergent adverse events		Up to 24 months
Secondary	Number and percentage of subjects with treatment-emergent adverse events associated with the treatment area (drug related)		Up to 24 months
Secondary	Number and percentage of subjects with treatment-emergent adverse events of special interest		Up to 24 months

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