Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

Kythera Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Moderate or Severe Submental Fullness

Treatments: Drug: Deoxycholic acid injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01032889

ATX-101-09-15

Details and patient eligibility

About

Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Enrollment: 129 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Moderate or severe submental fat
• Dissatisfaction with submental area
• History of stable body weight
• Signed informed consent

Exclusion criteria

• Any medical or other condition that would affect subject safety or evaluation of efficacy
• Previous intervention in the submental area

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Treatment:

Drug: Placebo

Deoxycholic acid Injection 1 mg/cm²

Experimental group

Description:

Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Treatment:

Drug: Deoxycholic acid injection

Deoxycholic acid Injection 2 mg/cm²

Experimental group

Description:

Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Treatment:

Drug: Deoxycholic acid injection