This was a long-term follow-up study of participants who completed Kythera-sponsored trials
      of ATX-101 (06-03, 07-07, 09-15)

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

Submental Fat

Healthy

No study medication was administered in this study.

Placebo

ATX-101 (1 mg/cm^2)

ATX-101 (2 mg/cm^2)

ATX-101 (4 mg/cm^2)

Long-term Follow-up Study of Subjects Who Completed Kythera-sponsored Trials of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.

The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.

The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.

Participants treated with placebo in previous ATX-101 studies

Participants treated with ATX-101 (1 mg/cm^2) in previous phase 2 studies

Participants treated with ATX-101 (2 mg/cm^2) in previous phase 2 studies

Participants treated with ATX-101 (4 mg/cm^2) in previous phase 2 studies

Total Skin & Beauty Dermatology Center

Clinical Testing Center Beverly Hills

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?